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  <VOL>76</VOL>
  <NO>108</NO>
  <DATE>Monday, June 6, 2011</DATE>
  <UNITNAME>Contents</UNITNAME>
  <CNTNTS>
    <AGCY>
      <EAR>Agriculture</EAR>
      <PRTPAGE P="iii"/>
      <HD>Agriculture Department</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Rural Business-Cooperative Service</P>
      </SEE>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Rural Utilities Service</P>
      </SEE>
    </AGCY>
    <AGCY>
      <EAR>Broadcasting</EAR>
      <HD>Broadcasting Board of Governors</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Privacy Act; Systems of Records,</DOC>
          <PGS>32355-32357</PGS>
          <FRDOCBP D="2" T="06JNN1.sgm">2011-13364</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Centers Medicare</EAR>
      <HD>Centers for Medicare &amp; Medicaid Services</HD>
      <CAT>
        <HD>RULES</HD>
        <SJ>Medicaid Programs:</SJ>
        <SJDENT>
          <SJDOC>Payment Adjustment for Provider Preventable Conditions Including Health Care Acquired Conditions,</SJDOC>
          <PGS>32816-32838</PGS>
          <FRDOCBP D="22" T="06JNR2.sgm">2011-13819</FRDOCBP>
        </SJDENT>
      </CAT>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <SJ>Medicare Program:</SJ>
        <SJDENT>
          <SJDOC>Five Year Review of Work Relative Value Units Under the Physician Fee Schedule,</SJDOC>
          <PGS>32410-32813</PGS>
          <FRDOCBP D="403" T="06JNP2.sgm">2011-13052</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Coast Guard</EAR>
      <HD>Coast Guard</HD>
      <CAT>
        <HD>RULES</HD>
        <DOCENT>
          <DOC>Limited Service Domestic Voyage Load Lines for River Barges on Lake Michigan,</DOC>
          <PGS>32323-32327</PGS>
          <FRDOCBP D="4" T="06JNR1.sgm">2011-13754</FRDOCBP>
        </DOCENT>
        <SJ>Regattas and Marine Parades:</SJ>
        <SJDENT>
          <SJDOC>Great Lakes Annual Marine Events,</SJDOC>
          <PGS>32313</PGS>
          <FRDOCBP D="0" T="06JNR1.sgm">2011-13759</FRDOCBP>
        </SJDENT>
        <SJ>Safety Zones:</SJ>
        <SJDENT>
          <SJDOC>Chelsea St. Bridge Demolition, Chelsea River, Chelsea, MA,</SJDOC>
          <PGS>32313-32316</PGS>
          <FRDOCBP D="3" T="06JNR1.sgm">2011-13838</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Commerce</EAR>
      <HD>Commerce Department</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>International Trade Administration</P>
      </SEE>
    </AGCY>
    <AGCY>
      <EAR>Community Development</EAR>
      <HD>Community Development Financial Institutions Fund</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>New Markets Tax Credit Program; Allocation Availability,</DOC>
          <PGS>32392-32403</PGS>
          <FRDOCBP D="11" T="06JNN1.sgm">2011-13864</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Comptroller</EAR>
      <HD>Comptroller of the Currency</HD>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <DOCENT>
          <DOC>Office of Thrift Supervision Integration; Dodd-Frank Act Implementation; Correction,</DOC>
          <PGS>32332</PGS>
          <FRDOCBP D="0" T="06JNP1.sgm">2011-13887</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Copyright Office</EAR>
      <HD>Copyright Office, Library of Congress</HD>
      <CAT>
        <HD>RULES</HD>
        <DOCENT>
          <DOC>Gap in Termination Provisions,</DOC>
          <PGS>32316-32321</PGS>
          <FRDOCBP D="5" T="06JNR1.sgm">2011-13845</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Defense Acquisition</EAR>
      <HD>Defense Acquisition Regulations System</HD>
      <CAT>
        <HD>RULES</HD>
        <SJ>Defense Federal Acquisition Regulation Supplements:</SJ>
        <SJDENT>
          <SJDOC>Agency Office of Inspector General,</SJDOC>
          <PGS>32840-32841</PGS>
          <FRDOCBP D="1" T="06JNR3.sgm">2011-13648</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Fire-Resistant Fiber for Production of Military Uniforms,</SJDOC>
          <PGS>32843-32844</PGS>
          <FRDOCBP D="1" T="06JNR3.sgm">2011-13368</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Foreign Acquisition Amendments,</SJDOC>
          <PGS>32841-32843</PGS>
          <FRDOCBP D="2" T="06JNR3.sgm">2011-13797</FRDOCBP>
        </SJDENT>
      </CAT>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <SJ>Defense Federal Acquisition Regulation Supplements:</SJ>
        <SJDENT>
          <SJDOC>Definition of Qualifying Country End Product,</SJDOC>
          <PGS>32845-32846</PGS>
          <FRDOCBP D="1" T="06JNP3.sgm">2011-13367</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Representation Relating to Compensation of Former DoD Officials,</SJDOC>
          <PGS>32846-32849</PGS>
          <FRDOCBP D="3" T="06JNP3.sgm">2011-13365</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Defense Department</EAR>
      <HD>Defense Department</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Defense Acquisition Regulations System</P>
      </SEE>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Navy Department</P>
      </SEE>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <DOCENT>
          <DOC>Reducing Regulatory Burden; Retrospective Review Under E.O. 13563,</DOC>
          <PGS>32330</PGS>
          <FRDOCBP D="0" T="06JNP1.sgm">2011-13765</FRDOCBP>
        </DOCENT>
      </CAT>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Meetings:</SJ>
        <SJDENT>
          <SJDOC>Advisory Council on Dependents Education,</SJDOC>
          <PGS>32358</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13874</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Defense Department Advisory Committee on Women in the Services,</SJDOC>
          <PGS>32358-32359</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13875</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Election</EAR>
      <HD>Election Assistance Commission</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Meetings; Sunshine Act,</DOC>
          <PGS>32359-32360</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13984</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Environmental Protection</EAR>
      <HD>Environmental Protection Agency</HD>
      <CAT>
        <HD>RULES</HD>
        <SJ>Approvals and Promulgations of Air Quality Implementation Plans:</SJ>
        <SJDENT>
          <SJDOC>Pennsylvania; Revision to Inspection and Maintenance Program—Quality Assurance Protocol, etc.,</SJDOC>
          <PGS>32321-32323</PGS>
          <FRDOCBP D="2" T="06JNR1.sgm">2011-13878</FRDOCBP>
        </SJDENT>
      </CAT>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <SJ>Approvals and Promulgations of Air Quality Implementation Plans:</SJ>
        <SJDENT>
          <SJDOC>Pennsylvania; Revision to Inspection and Maintenance Program—Quality Assurance Protocol, etc.,</SJDOC>
          <PGS>32333</PGS>
          <FRDOCBP D="0" T="06JNP1.sgm">2011-13879</FRDOCBP>
        </SJDENT>
        <SJ>Approvals and Promulgations of State Implementation Plans:</SJ>
        <SJDENT>
          <SJDOC>Texas; Revisions to New Source Review; Permit Renewals,</SJDOC>
          <PGS>32333-32340</PGS>
          <FRDOCBP D="7" T="06JNP1.sgm">2011-13872</FRDOCBP>
        </SJDENT>
      </CAT>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Proposed CERCLA Administrative De Minimis Settlements:</SJ>
        <SJDENT>
          <SJDOC>Casmalia Disposal Site,</SJDOC>
          <PGS>32360</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13877</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR/>
      <HD>Executive Office of the President</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Management and Budget Office</P>
      </SEE>
    </AGCY>
    <AGCY>
      <EAR>Farm Credit</EAR>
      <HD>Farm Credit Administration</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Meetings; Sunshine Act,</DOC>
          <PGS>32360</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-14030</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Federal Communications</EAR>
      <HD>Federal Communications Commission</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals,</DOC>
          <PGS>32360-32361</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13906</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Federal Deposit</EAR>
      <HD>Federal Deposit Insurance Corporation</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Updated Listing of Financial Institutions in Liquidation,</DOC>
          <PGS>32361</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13862</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Federal Emergency</EAR>
      <HD>Federal Emergency Management Agency</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
        <SJDENT>
          <SJDOC>Integrated Public Alert and Warning Systems Inventory,</SJDOC>
          <PGS>32367-32368</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13141</FRDOCBP>
        </SJDENT>
        <SJ>Emergency and Related Determinations:</SJ>
        <SJDENT>
          <SJDOC>Mississippi,</SJDOC>
          <PGS>32368-32369</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13896</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Tennessee,</SJDOC>
          <PGS>32369</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13913</FRDOCBP>
        </SJDENT>
        <SJ>Emergency Declarations:</SJ>
        <SJDENT>
          <SJDOC>North Dakota; Amendment No. 4,</SJDOC>
          <PGS>32369-32370</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13916</FRDOCBP>
        </SJDENT>
        <PRTPAGE P="iv"/>
        <SJ>Major Disaster Declarations:</SJ>
        <SJDENT>
          <SJDOC>Arkansas; Amendment No. 4,</SJDOC>
          <PGS>32371</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13915</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Kentucky; Amendment No. 7,</SJDOC>
          <PGS>32370</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13898</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Kentucky; Amendment No. 8,</SJDOC>
          <PGS>32370</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13895</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Minnesota; Amendment No. 1,</SJDOC>
          <PGS>32372</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13917</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Minnesota; Amendment No. 2,</SJDOC>
          <PGS>32371-32372</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13918</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Tennessee; Amendment No. 1,</SJDOC>
          <PGS>32371</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13897</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Tennessee; Amendment No. 2,</SJDOC>
          <PGS>32370-32371</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13914</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Federal Motor</EAR>
      <HD>Federal Motor Carrier Safety Administration</HD>
      <CAT>
        <HD>RULES</HD>
        <SJ>Regulatory Guidance:</SJ>
        <SJDENT>
          <SJDOC>Designation of Steerable Rear Axle Operators (Tillermen) as Drivers of Commercial Motor Vehicles,</SJDOC>
          <PGS>32327-32329</PGS>
          <FRDOCBP D="2" T="06JNR1.sgm">2011-13902</FRDOCBP>
        </SJDENT>
      </CAT>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
        <SJDENT>
          <SJDOC>Hours of Service of Drivers Regulations,</SJDOC>
          <PGS>32388-32390</PGS>
          <FRDOCBP D="2" T="06JNN1.sgm">2011-13900</FRDOCBP>
        </SJDENT>
        <SJ>Meetings:</SJ>
        <SJDENT>
          <SJDOC>Motor Carrier Safety Advisory Committee,</SJDOC>
          <PGS>32390-32391</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13899</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Federal Railroad</EAR>
      <HD>Federal Railroad Administration</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Meetings:</SJ>
        <SJDENT>
          <SJDOC>Northeast Corridor Safety Committee,</SJDOC>
          <PGS>32391</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13924</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Federal Reserve</EAR>
      <HD>Federal Reserve System</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Changes in Bank Control:</SJ>
        <SJDENT>
          <SJDOC>Acquisitions of Shares of a Bank or Bank Holding Company,</SJDOC>
          <PGS>32361-32362</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13883</FRDOCBP>
        </SJDENT>
        <DOCENT>
          <DOC>Formations of, Acquisitions by, and Mergers of Bank Holding Companies,</DOC>
          <PGS>32362</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13882</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Food and Drug</EAR>
      <HD>Food and Drug Administration</HD>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <SJ>Filings of Food Additive Petitions; Animal Use:</SJ>
        <SJDENT>
          <SJDOC>BASF Corp.; Methyl Esters of Conjugated Linoleic Acid; Silicon Dioxide,</SJDOC>
          <PGS>32332-32333</PGS>
          <FRDOCBP D="1" T="06JNP1.sgm">2011-13907</FRDOCBP>
        </SJDENT>
      </CAT>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
        <SJDENT>
          <SJDOC>Reports and Records Under Prescription Drug Marketing Act of 1987,</SJDOC>
          <PGS>32362-32364</PGS>
          <FRDOCBP D="2" T="06JNN1.sgm">2011-13442</FRDOCBP>
        </SJDENT>
        <DOCENT>
          <DOC>Collaboration in Regulatory Science and Capacity To Advance Global Access to Safe Vaccines and Biologicals,</DOC>
          <PGS>32364-32366</PGS>
          <FRDOCBP D="2" T="06JNN1.sgm">2011-13885</FRDOCBP>
        </DOCENT>
        <SJ>Determination That Product Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness:</SJ>
        <SJDENT>
          <SJDOC>ORLAAM (Levomethadyl Acetate Hydrochloride) Oral Solution, 10 Milligrams/Milliliter,</SJDOC>
          <PGS>32366-32367</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13884</FRDOCBP>
        </SJDENT>
        <SJ>Draft Guidance for Industry; Availability:</SJ>
        <SJDENT>
          <SJDOC>Financial Disclosure by Clinical Investigators; Correction,</SJDOC>
          <PGS>32367</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13871</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>General Services</EAR>
      <HD>General Services Administration</HD>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <SJ>Federal Travel Regulations:</SJ>
        <SJDENT>
          <SJDOC>Temporary Duty Travel Allowances (Taxes); Relocation Allowances (Taxes),</SJDOC>
          <PGS>32340-32354</PGS>
          <FRDOCBP D="14" T="06JNP1.sgm">2011-13356</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Health and Human</EAR>
      <HD>Health and Human Services Department</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Centers for Medicare &amp; Medicaid Services</P>
      </SEE>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Food and Drug Administration</P>
      </SEE>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <DOCENT>
          <DOC>Reducing Regulatory Burden;  Retrospective Review under Executive Order 13563,</DOC>
          <PGS>32330-32331</PGS>
          <FRDOCBP D="1" T="06JNP1.sgm">2011-13908</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Homeland</EAR>
      <HD>Homeland Security Department</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Coast Guard</P>
      </SEE>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Federal Emergency Management Agency</P>
      </SEE>
      <CAT>
        <HD>PROPOSED RULES</HD>
        <SJ>Retrospective Review under E.O. 13563:</SJ>
        <SJDENT>
          <SJDOC>Preliminary Plan,</SJDOC>
          <PGS>32331-32332</PGS>
          <FRDOCBP D="1" T="06JNP1.sgm">2011-13801</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Internal Revenue</EAR>
      <HD>Internal Revenue Service</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals,</DOC>
          <PGS>32403-32408</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13859</FRDOCBP>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13863</FRDOCBP>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13865</FRDOCBP>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13866</FRDOCBP>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13867</FRDOCBP>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13868</FRDOCBP>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13869</FRDOCBP>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13890</FRDOCBP>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13891</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>International Trade Adm</EAR>
      <HD>International Trade Administration</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Extension of Time Limit for Preliminary Results of Antidumping Duty Administrative Review:</SJ>
        <SJDENT>
          <SJDOC>Freshwater Crawfish Tail Meat From the People's Republic of China,</SJDOC>
          <PGS>32357-32358</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13909</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>International Trade Com</EAR>
      <HD>International Trade Commission</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Complaints,</DOC>
          <PGS>32372-32373</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13889</FRDOCBP>
        </DOCENT>
        <SJ>Investigations:</SJ>
        <SJDENT>
          <SJDOC>Certain Electronic Devices Having a Digital Television Receiver and Components Thereof,</SJDOC>
          <PGS>32373-32374</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13854</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Labor Department</EAR>
      <HD>Labor Department</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Occupational Safety and Health Administration</P>
      </SEE>
    </AGCY>
    <AGCY>
      <EAR>Library</EAR>
      <HD>Library of Congress</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Copyright Office, Library of Congress</P>
      </SEE>
    </AGCY>
    <AGCY>
      <EAR>Management</EAR>
      <HD>Management and Budget Office</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
        <SJDENT>
          <SJDOC>Partnership Fund for Program Integrity Innovation Pilot Idea Template,</SJDOC>
          <PGS>32375-32377</PGS>
          <FRDOCBP D="2" T="06JNN1.sgm">2011-13892</FRDOCBP>
        </SJDENT>
        <SJ>Audits of States, Local Governments, and Non-Profit Organizations:</SJ>
        <SJDENT>
          <SJDOC>OMB Circular A-133 Compliance Supplement,</SJDOC>
          <PGS>32377-32378</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13893</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>National Highway</EAR>
      <HD>National Highway Traffic Safety Administration</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Petitions for Decision that Nonconforming Vehicles Manufactured for the Mexican Market Are Eligible for Importation:</SJ>
        <SJDENT>
          <SJDOC>2007 Dodge Durango Multipurpose Passenger,</SJDOC>
          <PGS>32391-32392</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13888</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>National Science</EAR>
      <HD>National Science Foundation</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals,</DOC>
          <PGS>32378-32379</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13904</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Navy</EAR>
      <HD>Navy Department</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Privacy Act; Systems of Records,</DOC>
          <PGS>32359</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13873</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Nuclear Regulatory</EAR>
      <HD>Nuclear Regulatory Commission</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals,</DOC>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13852</FRDOCBP>
          <PGS>32379-32380</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13853</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Occupational Safety Health Adm</EAR>
      <PRTPAGE P="v"/>
      <HD>Occupational Safety and Health Administration</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Meetings:</SJ>
        <SJDENT>
          <SJDOC>National Advisory Committee on Occupational Safety and Health,</SJDOC>
          <PGS>32374-32375</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13901</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR/>
      <HD>Office of Management and Budget</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Management and Budget Office</P>
      </SEE>
    </AGCY>
    <AGCY>
      <EAR>Rural Business</EAR>
      <HD>Rural Business-Cooperative Service</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Funds Availability:</SJ>
        <SJDENT>
          <SJDOC>Biorefinery Assistance Program,</SJDOC>
          <PGS>32355</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13850</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Rural Utilities</EAR>
      <HD>Rural Utilities Service</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Funds Availability:</SJ>
        <SJDENT>
          <SJDOC>Biorefinery Assistance Program,</SJDOC>
          <PGS>32355</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13850</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Securities</EAR>
      <HD>Securities and Exchange Commission</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals,</DOC>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13856</FRDOCBP>
          <PGS>32380-32381</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13857</FRDOCBP>
        </DOCENT>
        <SJ>Self-Regulatory Organizations; Proposed Rule Changes:</SJ>
        <SJDENT>
          <SJDOC>International Securities Exchange, LLC,</SJDOC>
          <PGS>32382-32383</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13855</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>NASDAQ OMX BX,</SJDOC>
          <PGS>32383-32385</PGS>
          <FRDOCBP D="2" T="06JNN1.sgm">2011-13903</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>NASDAQ OMX PHLX LLC,</SJDOC>
          <PGS>32385-32387</PGS>
          <FRDOCBP D="2" T="06JNN1.sgm">2011-13876</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Small Business</EAR>
      <HD>Small Business Administration</HD>
      <CAT>
        <HD>NOTICES</HD>
        <SJ>Disaster Declarations:</SJ>
        <SJDENT>
          <SJDOC>Kentucky; Amendment 2,</SJDOC>
          <PGS>32387</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13846</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Kentucky; Amendment 4,</SJDOC>
          <PGS>32387-32388</PGS>
          <FRDOCBP D="1" T="06JNN1.sgm">2011-13848</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Minnesota; Amendment 1,</SJDOC>
          <PGS>32388</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13849</FRDOCBP>
        </SJDENT>
        <SJDENT>
          <SJDOC>Tennessee; Amendment 1,</SJDOC>
          <PGS>32387</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13847</FRDOCBP>
        </SJDENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>State Department</EAR>
      <HD>State Department</HD>
      <CAT>
        <HD>NOTICES</HD>
        <DOCENT>
          <DOC>Determination and Waiver Relating to Assistance for the Independent States of the Former Soviet Union,</DOC>
          <PGS>32388</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13920</FRDOCBP>
        </DOCENT>
        <DOCENT>
          <DOC>Waiver of Restriction on Assistance to Central Government of Dominican Republic,</DOC>
          <PGS>32388</PGS>
          <FRDOCBP D="0" T="06JNN1.sgm">2011-13919</FRDOCBP>
        </DOCENT>
      </CAT>
    </AGCY>
    <AGCY>
      <EAR>Transportation Department</EAR>
      <HD>Transportation Department</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Federal Motor Carrier Safety Administration</P>
      </SEE>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Federal Railroad Administration</P>
      </SEE>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>National Highway Traffic Safety Administration</P>
      </SEE>
    </AGCY>
    <AGCY>
      <EAR>Treasury</EAR>
      <HD>Treasury Department</HD>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Community Development Financial Institutions Fund</P>
      </SEE>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Comptroller of the Currency</P>
      </SEE>
      <SEE>
        <HD SOURCE="HED">See</HD>
        <P>Internal Revenue Service</P>
      </SEE>
    </AGCY>
    <PTS>
      <HD SOURCE="HED">Separate Parts In This Issue</HD>
      <HD>Part II</HD>
      <DOCENT>
        <DOC>Health and Human Services Department, Centers for Medicare &amp; Medicaid Services,</DOC>
        <PGS>32410-32813</PGS>
        <FRDOCBP D="403" T="06JNP2.sgm">2011-13052</FRDOCBP>
      </DOCENT>
      <HD>Part III</HD>
      <DOCENT>
        <DOC>Health and Human Services Department, Centers for Medicare &amp; Medicaid Services,</DOC>
        <PGS>32816-32838</PGS>
        <FRDOCBP D="22" T="06JNR2.sgm">2011-13819</FRDOCBP>
      </DOCENT>
      <HD>Part IV</HD>
      <DOCENT>
        <DOC>Defense Department, Defense Acquisition Regulations System,</DOC>
        <PGS>32840-32849</PGS>
        <FRDOCBP D="1" T="06JNR3.sgm">2011-13648</FRDOCBP>
        <FRDOCBP D="1" T="06JNR3.sgm">2011-13368</FRDOCBP>
        <FRDOCBP D="2" T="06JNR3.sgm">2011-13797</FRDOCBP>
        <FRDOCBP D="1" T="06JNP3.sgm">2011-13367</FRDOCBP>
        <FRDOCBP D="3" T="06JNP3.sgm">2011-13365</FRDOCBP>
      </DOCENT>
    </PTS>
    <AIDS>
      <HD SOURCE="HED">Reader Aids</HD>
      <P>Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.</P>
      
      <P>To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.</P>
    </AIDS>
  </CNTNTS>
  <VOL>76</VOL>
  <NO>108</NO>
  <DATE>Monday, June 6, 2011</DATE>
  <UNITNAME>Rules and Regulations</UNITNAME>
  <RULES>
    <RULE>
      <PREAMB>
        <PRTPAGE P="32313"/>
        <AGENCY TYPE="F">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Coast Guard</SUBAGY>
        <CFR>33 CFR Part 100</CFR>
        <DEPDOC>[Docket No. USCG-2010-0409]</DEPDOC>
        <SUBJECT>Regattas and Marine Parades; Great Lakes Annual Marine Events</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Coast Guard, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of enforcement of regulation.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Coast Guard will enforce various local regulations for annual regattas and marine parades in the Captain of the Port Detroit zone from 8 a.m. on June 24, 2011 through 6 p.m. on July 31, 2011. This action is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after regattas or marine parades. This rule will establish restrictions upon, and control movement of, vessels in specified areas immediately prior to, during, and immediately after regattas or marine parades. During the enforcement periods, no person or vessel may enter the regulated areas without permission of the Captain of the Port.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>The regulations in 33 CFR 100.914, 100.915, 100.918, and 100.919 will be enforced at various times between June 24, 2011 and July 31, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>If you have questions on this notice, call or e-mail LT Katie Stanko, Prevention Department, Sector Detroit, Coast Guard; telephone (313) 568-9508, e-mail<E T="03">Katie.R.Stanko@uscg.mil.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The Coast Guard will enforce the following special local regulations at the following times:</P>
        <SECTION>
          <SECTNO>§ 100.919</SECTNO>
          <SUBJECT>International Bay City River Roar, Bay City, MI.</SUBJECT>
          <P>This special local regulation will be enforced from 8 a.m. to 5:30 p.m. on June 24, 2011 and from 9 a.m. to 6 p.m. on June 25 and 26, 2011. In the case of inclement weather on June 26, 2011, this special local regulation will be enforced from 9 a.m. to 6 p.m. on June 27, 2011.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 100.914</SECTNO>
          <SUBJECT>Trenton Rotary Roar on the River, Trenton, MI.</SUBJECT>
          <P>This special local regulation will be enforced from 2 p.m. to 6 p.m. on July 22, 2011 and from 8 a.m. to 8 p.m. on July 23 and 24, 2011.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 100.915</SECTNO>
          <SUBJECT>St. Clair River Classic Offshore Race, St. Clair, MI.</SUBJECT>
          <P>This special local regulation will be enforced daily from 10 a.m. to 6 p.m. on July 29, 30 and 31, 2011.</P>
          <P>
            <E T="03">Regulations:</E>
          </P>
          <P>(1) In accordance with the general regulations in 33 CFR 100.901, entry into, transiting, or anchoring within these regulated areas is prohibited unless authorized by the Captain of the Port Detroit, or his designated on-scene representative.</P>
          <P>(2) These regulated areas are closed to all vessel traffic, except as may be permitted by the Captain of the Port Detroit or his designated on-scene representative.</P>
          <P>(3) The “designated on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant, or petty officer who has been designated by the Captain of the Port to act on his behalf. The designated on-scene representative of the Captain of the Port will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Captain of the Port or his designated on scene representative may be contacted via VHF Channel 16.</P>
          <P>(4) Vessel operators desiring to enter or operate within the regulated area shall contact the Captain of the Port Detroit or his designated on-scene representative to obtain permission.</P>
          <P>(5) Vessel operators given permission to enter or operate in the regulated area must comply with all directions given to them by the Captain of the Port or his designated on-scene representative.</P>
        </SECTION>
        <SIG>
          <DATED>Dated: May 19, 2011.</DATED>
          <NAME>J.E. Ogden,</NAME>
          <TITLE>Captain, U.S. Coast Guard, Captain of the Port Detroit.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13759 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9110-04-P</BILCOD>
    </RULE>
    <RULE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Coast Guard</SUBAGY>
        <CFR>33 CFR Part 165</CFR>
        <DEPDOC>[Docket No. USCG-2011-0420]</DEPDOC>
        <RIN>RIN 1625-AA00</RIN>
        <SUBJECT>Safety Zone; Chelsea St. Bridge Demolition, Chelsea River, Chelsea, MA</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Coast Guard, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Temporary final rule.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Coast Guard is establishing a temporary safety zone within the Sector Boston Captain of the Port (COTP) Zone for the demolition of the Chelsea St. Bridge. This safety zone is necessary to provide for the safety of life on navigable waters during the demolition operations. Entering into, transiting through, mooring or anchoring within this zone is prohibited unless authorized by the COTP or the designated on-scene representative.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>This rule is effective and will be enforced from 7 a.m. on June 6, 2011 to 7 a.m. on June 9, 2011.</P>
        </EFFDATE>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>Documents indicated in this preamble as being available in the docket are part of docket USCG-2011-0420 are available online by going to<E T="03">http://www.regulations.gov,</E>inserting USCG-2011-0420 in the “Keyword” box, and then clicking “Search.” They are also available for inspection or copying at the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>If you have questions on this temporary rule, call or e-mail MST1 David Labadie of the Waterways Management Division, U.S. Coast Guard Sector Boston; telephone 617-223-3010, e-mail<E T="03">david.j.labadie@uscg.mil.</E>If you have questions on viewing material related to<PRTPAGE P="32314"/>the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">Regulatory Information</HD>
        <P>The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because sufficient information regarding the dates of the demolition activities was not received in time to publish a NPRM followed by a final rule as the demolition would occur before the rulemaking process was complete.</P>

        <P>The Chelsea Street Bridge will need to be demolished between June 6, and June 9, 2011. It is crucial to the operation of the waterway that this $127 million-project remains on schedule, beginning with the demolition of the existing bridge. There is a very complex timeline required to be followed to ensure this waterway remains operational, ensuring product delivery vital to New England, namely petroleum products (<E T="03">e.g.</E>heating oil and gasoline). If the bridge construction project is held up or off schedule it would have serious ramifications to the waterway stakeholders. Due to the dangers posed by the demolition of such a large structure over a waterway, the safety zone is necessary to provide for the safety of any vessels transiting the area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the demolition.</P>

        <P>Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the<E T="04">Federal Register.</E>Any delay in the effective date of this rule would expose vessels and other property to the hazards associated with demolition of such a large structure over the waterway.</P>
        <HD SOURCE="HD1">Basis and Purpose</HD>
        <P>The legal basis for the temporary rule is 33 U.S.C. 1226, 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define safety zones.</P>
        <P>The safety zone is being issued to establish a temporary limited access area on the Chelsea River around the existing Chelsea St. Bridge during the operations surrounding the bridge's demolition and removal.</P>
        <HD SOURCE="HD1">Discussion of Rule</HD>
        <P>This temporary rule is necessary to ensure the safety of vessels and other property from the hazards associated with bridge demolition operations. The COTP Boston has determined that the demolition of such a large structure over the waterway poses a significant risk to public safety and property. Hazards include obstructions to the waterway that may contribute to marine casualties, such as crane barges, work vessels, and construction equipment, and large pieces of debris falling into the water that may cause death or serious bodily harm. Establishing a safety zone around the location of the demolition operations will help ensure the safety of vessels and other property and help minimize the associated risks.</P>
        <P>The Coast Guard has been coordinating with contractors and local stakeholders regarding the scope of the overall project. The stakeholders that may be affected by this limited access area have been involved with the planning of this project and are aware of the potential impacts to waterway from this project.</P>
        <P>Vessels may enter or transit through this safety zone during this time frame if authorized by the COTP Boston or the designated representative.</P>
        <P>The COTP will cause notice of enforcement or suspension of enforcement of this safety zone to be made by all appropriate means to affect the widest distribution among the affected segments of the public. Such means of notification will include, but is not limited to, Broadcast Notice to Mariners and Local Notice to Mariners.</P>
        <HD SOURCE="HD1">Regulatory Analyses</HD>
        <P>We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.</P>
        <HD SOURCE="HD1">Executive Order 12866 and Executive Order 13563</HD>
        <P>This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.</P>
        <P>The Coast Guard determined that this rule is not a significant regulatory action for the following reasons: The safety zone will be of limited duration, is located in a waterway that has no recreational boating traffic; commercial traffic and potentially affected terminal operators have been consulted and will coordinate their vessels transits to avoid, to the extent possible, any disruptions in normal operations.</P>
        <P>Persons and/or vessels may enter the safety zone if they obtain permission from the Coast Guard COTP, Boston.</P>
        <P>Notifications will be made to the local maritime community through the Local Notice to Mariners and Broadcast Notice to Mariners well in advance of the demolition.</P>
        <HD SOURCE="HD1">Small Entities</HD>
        <P>Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.</P>
        <P>The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.</P>
        <P>This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, moor or anchor in portions of the Chelsea River during bridge demolition operations.</P>
        <P>This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: Vessels will only be restricted from this safety zone for a short duration of time. Persons and/or vessels may enter the safety zone if they obtain permission from the Coast Guard COTP, Boston. Potentially affected waterway users have plans in place to coordinate their vessel transits to avoid, to the extent possible, any disruptions in normal operations. There is no recreational boating traffic located in this waterway.</P>

        <P>Notifications will be made to the local maritime community through the Local Notice to Mariners and Broadcast Notice to Mariners well in advance of the demolition.<PRTPAGE P="32315"/>
        </P>
        <HD SOURCE="HD1">Assistance for Small Entities</HD>

        <P>Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact MST1 David Labadie at the telephone number or e-mail address indicated under the<E T="02">FOR FURTHER INFORMATION CONTACT</E>section of this notice.</P>
        <P>Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.</P>
        <HD SOURCE="HD1">Collection of Information</HD>
        <P>This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).</P>
        <HD SOURCE="HD1">Federalism</HD>
        <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.</P>
        <HD SOURCE="HD1">Unfunded Mandates Reform Act</HD>
        <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.</P>
        <HD SOURCE="HD1">Taking of Private Property</HD>
        <P>This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.</P>
        <HD SOURCE="HD1">Civil Justice Reform</HD>
        <P>This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.</P>
        <HD SOURCE="HD1">Protection of Children</HD>
        <P>We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.</P>
        <HD SOURCE="HD1">Indian Tribal Governments</HD>
        <P>This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.</P>
        <HD SOURCE="HD1">Energy Effects</HD>
        <P>We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.</P>
        <HD SOURCE="HD1">Technical Standards</HD>
        <P>The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.</P>
        <P>This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.</P>
        <HD SOURCE="HD1">Environment</HD>

        <P>We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the establishment of a safety zone. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under<E T="02">ADDRESSES</E>.</P>
        <LSTSUB>
          <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
          <P>Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.</P>
        </LSTSUB>
        
        <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows:</P>
        <REGTEXT PART="165" TITLE="33">
          <PART>
            <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS</HD>
          </PART>
          <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.</P>
          </AUTH>
          
        </REGTEXT>
        <REGTEXT PART="165" TITLE="33">
          <AMDPAR>2. Add § 165.T01-0420 to read as follows:</AMDPAR>
          <SECTION>
            <SECTNO>§ 165.T01-0420</SECTNO>
            <SUBJECT>Chelsea St. Bridge Demolition, Chelsea River, Chelsea, Massachusetts.</SUBJECT>
            <P>(a)<E T="03">General.</E>A temporary safety zone is established for the bridge demolition as follows:</P>
            <P>(1)<E T="03">Location.</E>All waters of the Chelsea River, from surface to bottom, within the following points (NAD 83):</P>
            
            <FP SOURCE="FP-2">42°23.10′ N, 071°01.26′ W.</FP>
            <FP SOURCE="FP-2">42°23.15′ N, 071°01.20′ W.</FP>
            <FP SOURCE="FP-2">42°23.10′ N, 071°01.17′ W.</FP>
            <FP SOURCE="FP-2">42°23.07′ N, 070°01.24′ W.</FP>
            
            <PRTPAGE P="32316"/>
            <P>(2)<E T="03">Enforcement period.</E>This rule is effective and will be enforced from 7 a.m. on June 6, 2011 to 7 a.m. on June 9, 2011.</P>
            <P>(b)<E T="03">Regulations.</E>(1) In accordance with the general regulations in § 165.23 of this part, entering into, transiting through, mooring or anchoring within this regulated area is prohibited unless authorized by the Captain of the Port (COTP) Boston, or the designated on-scene representative.</P>
            <P>(2) The “on-scene representative” is any Coast Guard commissioned, warrant, or petty officer who has been designated by the COTP Boston to act on his behalf. The on-scene representative will be aboard either a Coast Guard or Coast Guard Auxiliary vessel.</P>
            <P>(3) Vessel operators desiring to enter or operate within the regulated area shall contact the COTP or the designated on-scene representative via VHF channel 16 or 617-223-5750 (Sector Boston command center) to obtain permission to do so.</P>
            <P>(4) Vessel operators given permission to enter or operate in the regulated area must comply with all directions given to them by the COTP or the designated on-scene representative.</P>
            <P>(5) Notice of suspension of enforcement: The COTP Sector Boston may temporarily suspend enforcement of the safety zone. If enforcement is suspended, the COTP will cause a notice of the suspension of enforcement by all appropriate means to affect the widest publicity among the affected segments of the public. Such means of notification may also include, but are not limited to, Broadcast Notice to Mariners and Local Notice to Mariners. Such notification will include the date and time that enforcement is suspended as well as the date and time that enforcement will resume.</P>
          </SECTION>
        </REGTEXT>
        <SIG>
          <DATED>Dated: May 24, 2011.</DATED>
          <NAME>John N. Healey,</NAME>
          <TITLE>Captain, U.S. Coast Guard, Captain of the Port Boston.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13838 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9110-04-P</BILCOD>
    </RULE>
    <RULE>
      <PREAMB>
        <AGENCY TYPE="N">LIBRARY OF CONGRESS</AGENCY>
        <SUBAGY>Copyright Office</SUBAGY>
        <CFR>37 CFR Part 201</CFR>
        <DEPDOC>[Docket No. RM 2010-5]</DEPDOC>
        <SUBJECT>Gap in Termination Provisions</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Copyright Office, Library of Congress.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Final rule.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Copyright Office is amending its regulations governing notices of termination of certain grants of transfers and licenses of copyright under section 203 of the Copyright Act. The amendments are intended to clarify the recordation practices of the Copyright Office regarding the content of certain notices of termination, and the circumstances under which such notices will be accepted by the Office. In particular, they clarify that the Copyright Office will record section 203 notices of termination of grants for works created after 1977 even when the agreement to make a grant was made before 1978.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Effective Date: June 6, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>David O. Carson, General Counsel, P.O. Box 70400, Washington, DC 20024.<E T="03">Telephone:</E>(202) 707-8380.<E T="03">Telefax:</E>(202) 707-8366. All prior<E T="04">Federal Register</E>notices and public comments in this docket and a related inquiry are available at<E T="03">http://www.copyright.gov/docs/termination</E>.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">Background</HD>
        <P>The Copyright Act gives authors (and some heirs, beneficiaries and representatives who are specified by statute) the right to terminate certain grants of transfers or licenses within the time frames set forth in the statute and subject to the execution of certain conditions precedent. Termination rights (also referred to as “recapture rights”) are equitable accommodations under the law. They allow authors or their heirs a second opportunity to share in the economic success of their works. These termination rights are codified in sections 203, 304(c), 304(d) and 203 of Title 17 of the United States Code. They do not apply to copyrights in works made for hire or grants made by will. Sections 304(c) and 304(d) establish termination rights for works that had subsisting copyrights on January 1, 1978, the effective date of the 1976 Copyright Act. Section 203, which is the subject of this rulemaking, establishes termination rights for works subject to grants of transfers or licenses made on or after the effective date of the 1976 Copyright Act, but only to the extent they were executed by the author.</P>
        <P>The current rulemaking addresses a narrow fact pattern that was also the subject of a related notice of inquiry published March 29, 2010. (75 FR 15390). Through the notice of inquiry, the Office sought comments as to whether or how the termination provisions apply in circumstances where an author agreed to make a grant prior to January 1, 1978, but the work in question was created on or after January 1, 1978—circumstances raised by some authors and songwriters and their representatives in discussions with the Copyright Office and some congressional offices. Such grants are sometimes called “Gap Grants” in light of a perception that in creating the section 304 termination process and the section 203 termination process, as described above, Congress may have created a “gap” by failing to address circumstances in which authors (or would-be authors) agreed to make grants prospectively, before January 1, 1978, for works they did not create until on or after that date.</P>

        <P>In response to the Notice of Inquiry seeking comments on the so-called “gap,” the Copyright Office received sixteen initial comments and nine reply comments. These comments are available online on the Copyright Office Web site, at<E T="03">http://www.copyright.gov/docs/termination/</E>. Most concluded that the termination right provided in section 203 of the Copyright Act is applicable to Gap Grants as currently codified, reasoning that a grant is not fully executed under the law until the relevant work has been created. Multiple commenters expanded on this point, observing, in turn, that there can be no author, no copyright interest and no grant of copyright under Title 17 until there is first a work of authorship. One comment, however, urged caution, questioning whether, at least in the case of written grants, Congress intended the date of execution for the purposes of section 203 to mean the date the grant was signed. This view could not apply to grants made orally, but it would mean section 203 cannot apply to any fact patterns in which grants are executed in writing and signed prior to January 1, 1978.</P>

        <P>Based on the comments received and its own analysis, the Copyright Office concluded that the better interpretation of the law is that Gap Grants<E T="03">are</E>terminable under section 203, as currently codified, because as a matter of copyright law, a transfer that predates the existence of the copyrighted work cannot be effective (and therefore cannot be “executed”) until the work of authorship (and the copyright) come into existence. In arriving at this conclusion, the Copyright Office looked at the plain meaning of Title 17, including section 203, as well as the legislative history of the termination provisions. It also considered transfer of copyrights and renewal rights under common law, prior to enactment of the termination provisions<E T="03">. See Analysis of Gap Grants Under the Termination<PRTPAGE P="32317"/>Provisions of Title 17</E>(December 7, 2010), available at<E T="03">http://www.copyright.gov/reports/gap-grant%20analysis.pdf</E>(hereinafter the “December Analysis”).</P>

        <P>In the December Analysis, the Copyright Office also concluded that legislation to clarify the statute would be beneficial, not only to better achieve the policy objectives for book authors, songwriters and other intended beneficiaries of the provision, but in order to provide confidence and certainty for publishers and other grantees with respect to copyright title, transfers and licensing transactions in the marketplace.<E T="03">Id.</E>And the Office acknowledged that its own recordation practices required clarification, so that stakeholders would know whether and how to timely record termination notices pertaining to gap grants.<E T="03">Id.</E>
        </P>

        <P>The Office's recordation practices are the focus of the current rulemaking, initiated in a notice of proposed rulemaking published in November. 75 FR 72771 (November 26, 2010). In the notice of proposed rulemaking, the Office stated its current practices, which permit the recordation of a notice of termination under section 203 when the notice states that the grant was executed on a specified date that is on or after January 1, 1978. It observed that a person serving and submitting a notice of termination based on the rationale described above would be justified in including in the notice, as the date of execution of the grant, the date that the work was created, and that for purposes of clearly identifying the grant being terminated, it may be useful (in the case of written grants) also to state the date the grant was signed. Such recordation by the Office would be without prejudice as to how a court might ultimately rule on whether the document is a notice of termination within the scope of section 203.<E T="03">See</E>37 CFR 201.10(f)(5).</P>
        <P>The notice of proposed rulemaking sought comment on amendments to Copyright Office regulations that would clarify that, consistent with existing recordation practices, the Office reserves the right to refuse a document for recordation as a section 203 notice of termination if the date of execution of the grant, as reflected in the document submitted as a notice of termination, falls before January 1, 1978. The notice proposed an amendment to the existing regulations on notices of termination that would clarify certain circumstances under which, based on certain procedural failures drawn from the clear language of the Copyright Act, the Office will refuse to index as notices of termination documents submitted under section 203. These circumstances included a recital in a notice of termination of a date of execution of the grant that falls before January 1, 1978 (as discussed above), an effective date of termination that does not fall within the allowed statutory period (17 U.S.C. 203(a)(3)), improperly timed service of the notice of termination (17 U.S.C. 203(a)(4)(A)), or submission of documents for recordation as notice of termination on or after the effective date of termination (17 U.S.C. 203(a)(4)(A)).</P>
        <P>Specifically, the notice of proposed rulemaking proposed to amend § 201.10(f)(4) of the Copyright Office regulations, which currently provides that the Copyright Office reserves the right to refuse recordation of a notice of termination if, in the judgment of the Copyright Office, such notice of termination is untimely, by adding the following language: “Conditions under which a notice of termination will be considered untimely include: The date of execution stated therein does not fall on or after January 1, 1978, as required by section 203(a) of title 17, United States Code; the effective date of termination does not fall within the five-year period described in section 203(a)(3) of title 17, United States Code; or the documents submitted indicate that the notice of termination was served less than two or more than ten years before the effective date of termination.”</P>
        <P>The effect of the proposed amendment would have been that if a notice of termination of a Gap Grant provided, as the date of execution of the grant, a date on or after January 1, 1978, the Office would record the notice as a notice of termination under section 203. The Office would not question that date even if it knew that an agreement to grant the transfer or license was signed before January 1, 1978, since there would be legitimate grounds to conclude that the grant could not actually have been “executed” until the work that was the subject of the grant had been created.</P>
        <HD SOURCE="HD1">Comments</HD>
        <P>The Office received seven comments in response to the notice of proposed rulemaking. All of the commenters expressed support for the general proposition that the Office should record notices of termination of Gap Grants, although not all necessarily agreed that such notices actually meet the requirements for notices of termination under section 203.</P>
        <P>Most groups representing authors and performers who submitted comments generally supported the proposed rule, although some proposed more extensive regulation. The Future of Music Coalition characterized the proposal as “an appropriate compromise to facilitate the notice of termination filing requirements for Gap Grants,” but noted that “this rulemaking is not a substitute for statutory clarification.” It noted that under an approach that bases the date of execution of a grant upon the date the work was created, there may be difficulties in establishing the actual date of creation of the work and noted that an approach that considers the date of creation to be the date of execution would be less friendly to authors, especially when individual contracts apply to works created piecemeal or involve the transfer of multiple future works.</P>
        <P>In a jointly filed comment, The Authors Guild and the Songwriters Guild of America endorsed the Copyright Office's December Analysis as well as the proposed regulation, but suggested a further amendment that would affirmatively state that the Office will record notices of termination of Gap Grants under section 203. They proposed the following language: “Notices of termination for works created on or after January 1, 1978, the grants of transfers and licenses of copyrights for which were entered into before January 1, 1978, will be accepted under section 203.”</P>
        <P>Attorney Casey del Casino's comment characterized the proposed regulation as “an important step in addressing and attempting to correct what is clearly an oversight on the part of Congress with respect to so-called `gap works,' ” but noted that “the use of the date of creation in the proposed rule change, while doctrinally sound, may in reality be problematic” because the date of creation of a work is not always easy to ascertain, especially if the specific date of creation must be recited in the notice of termination. He suggested that the problem could be ameliorated if only the year of creation must be provided. Alternatively, he suggested that when the date of creation is unknown or unascertainable, it should be sufficient to provide the date of publication, a date which is generally easier to determine. Karyn Soroka of Soroka Music Ltd. offered a similar comment.</P>

        <P>Attorneys Michael Perlstein, Bill Gable and Kenneth Freundlich also expressed concern about practical difficulties likely to generate litigation if further clarification could not be achieved through legislation or “best practices,” noting that “neither authors nor their grantees (<E T="03">e.g.</E>publishing companies) were ever on notice that they needed to retain documents evidencing date of creation (as<PRTPAGE P="32318"/>distinguished from date of delivery, for example), and that even if such documents may once have existed neither party often will have preserved them.” They therefore proposed guidelines that they characterized as “author-friendly, consistent with legislative and judicial intent that authors and their heirs benefit from the termination statutes.” These guidelines proposed a hierarchy of five criteria to be used to determine the date of execution of a grant, culminating in a default rule for unpublished works with no registered copyright and no author-provided proof of creation. In such cases, there would be a rebuttable presumption the work was created (which thereby executed the grant) on the statutorily fixed date of January 1, 1978.</P>
        <P>Those representing grantees of rights also supported the Office's proposal to amend its regulations to make clear that the Office will record notices of termination of Gap Grants, but they sought additional amendments that they believe would make it clearer that recordation does not mean the notices are legally valid. In other words, they argued that the Office should take care to articulate that its acceptance and recordation of Gap Grants under section 203 is without prejudice to a court ruling that Gap Grants are not terminable as a matter of law.</P>
        <P>For example, the Software and Information Industry Association (SIIA) stated that the better practice would be for the Copyright Office to leave any merits-based evaluation to the courts and suggested that the amended regulation clarify that the Office's decision to record such terminations has been made simply to help preserve the filing party's rights, reserving the ultimate determination of the issue for the courts. While acknowledging that the Office has concluded that there are legitimate grounds to conclude that Gap Grants may be terminated under section 203 because they could not have been “executed” before the works subject to the grants were actually created, SIIA requested that the amended regulation make clear that “there are also legitimate grounds to assert that in the case of a grant signed (or, in the case of an oral license, agreed to) before January 1, 1978 regarding rights in a work not created until January 1, 1978 or later, such a grant was `executed' on the date such grant was signed and that the termination provisions of section 203 of Title 17 do not apply to any such grants”; that “the Copyright Office was not and is not making any merit-based evaluation of the arguments either way”; and that the regulation “simply would act to help preserve the filing party's rights, reserving the ultimate determination of the issue for the courts.” SIIA Comment at 2.</P>
        <P>The Recording Industry Association of America (RIAA) raised the same point as SIAA, as well as a finer point the Office had not previously considered. It observed that the proposed amendment would recite the Copyright Office's right to refuse to record a notice of termination if, in the judgment of the Office, the notice is untimely, but also would treat the recital by an author of the date of execution (in the notice of termination itself) as an issue relating to timeliness of the notice. As a result, the Office's act of recording a notice of termination of a Gap Grant could be construed as a judgment by the Office that the particular notice is timely. Having defined the issue of date of execution of the grant as an issue relating to timeliness of the notice, the effect of the regulation might be to give the Office's judgment as to timeliness in such cases greater weight than the Office intended.</P>
        <HD SOURCE="HD1">Discussion</HD>
        <P>The Copyright Office recognizes the practical concerns raised by some commenters with respect to establishing an effective date of execution based on the date of creation of a work. How does one recall and prove the date of creation, especially in the absence of supporting documentation? The task is obviously challenging, but it is not unique to Gap Grants and it is not new. For example, authors who wish to terminate oral agreements (grants of nonexclusive rights do not require a signed writing) must reconstruct dates from memory or supporting conduct or documentation. To be clear, the Copyright Office is not suggesting that requiring authors to reconstruct precise dates decades after the fact is an optimal policy solution; it is merely pointing out that the challenges exist irrespective of Gap Grant scenarios. Indeed, as noted in the December Analysis, the challenges will be ongoing for purposes of section 203. That is, in every instance where a grant of rights has been or will be made prospectively, whether in writing or orally, the author will need to determine the date of execution of the grant separately from the date the grant was initiated, in order to secure an effective date of termination. This would seem to be a particular problem for grants that did not or will not cover the publication right, although this too is not entirely clear. When the grant covers the publication right, section 203 allows for termination during a 5-year window commencing 35 years from publication or 40 years from the date of execution of the grant, whichever is sooner. Thus the question: can an author perform the statutory calculation if she cannot ascertain both a date of execution of the grant and (if the work was published) a publication date?</P>
        <P>The proposals of some commenters were aimed at simplifying the practical challenges noted above and providing guidance to authors and grantees alike for the sake of the marketplace. Consider, for example, the suggested hierarchy of five criteria to be used to determine the date of execution of a grant that was proposed by Mr. Perlstein, Mr. Gable and Mr. Freundlich (including the suggestion that the date of publication may be used as a proxy) and the year of creation solution proposed by Mr. del Casino. While these may be useful ideas, they beg some important questions: Does the Copyright Office have the authority to promulgate these kinds of solutions under its rulemaking authority? And if it does, are such regulations within the scope of the regulatory action that was proposed in the current rulemaking?</P>

        <P>Starting with the latter point, the current rulemaking sought comment on a proposal to make limited procedural revisions to existing Copyright Office regulations. These revisions would make clear that as long as the notice of termination identified the date of execution of the grant as a date on or after January 1, 1978, the Office would not refuse to record it for lack of timeliness. In explaining the reasons for the proposed regulatory amendment, the notice observed, consistent with many comments submitted in response to the March 2010 notice of inquiry, that “there are legitimate grounds to assert that, in the case of a grant signed (or, in the case of an oral license, agreed to) before January 1, 1978 regarding rights in a work not created until January 1, 1978 or later, such a grant cannot be `executed' until the work exists.” 75 FR 72772, (November 26, 2010). Therefore, “[a] person serving and submitting a notice of termination based on the rationale described above would be justified in including in the notice, as the date of execution of the grant, the date that the work was created.”<E T="03">Id.</E>This is the rationale the Copyright Office later found to be persuasive and documented in its December Analysis.</P>

        <P>The Copyright Office notes that some of the alternative solutions proposed in some of the comments submitted by representatives of authors appear to go beyond the scope of the limited procedural rule governing recordation practice that was proposed in this rulemaking proceeding. Moreover, none<PRTPAGE P="32319"/>of the commenters who urged caution in response to the Office's proposal have had an opportunity to respond to the new proposals made in those comments. The Office concludes that to adopt a rule that goes beyond that which was proposed in the notice of proposed rulemaking would be beyond the scope of the current rulemaking and would require notice and opportunity for further comment by all interested parties. The Office does not wish to postpone the issuance of a final regulation in the current rulemaking, but is considering publishing a new notice of inquiry that will address the additional proposals.</P>

        <P>The Office also has questions regarding the scope of its regulatory authority to publish new proposals, practical solutions or alternatives to documenting the date of execution of the grant, even in instances when said date is elusive by reasonable standards and where many stakeholders would welcome guidance. As a general matter, the Copyright Office is authorized to issue regulations based upon existing law and the statutory grant of authority to establish regulations for the administration of the statutory functions and duties made the responsibility of the Office, such as the administration of a recordation program.<E T="03">See</E>17 U.S.C. 702. Moreover, the existing regulations, as well as the final regulation adopted today, follow Copyright Office practice with respect to the content of notices of termination. Since the Office first issued regulations governing notices of termination in 1977, the regulations have provided that a notice of termination must recite the relevant date used to calculate the period during which termination may be effected.<E T="03">See</E>Final Regulation, Termination of Transfers and Licenses Covering Extended Renewal Term, 42 FR 45916, 45917 (September 13, 1977) (imposing requirement, for notices of termination under section 304(c), that notices recite the date copyright was secured because “the period during which termination may be effected is measured from the date copyright was originally secured”). When the Office first proposed regulations governing notices of termination under section 203, it proposed that such notices include “identification of the date of execution of the grant being terminated” for the same reason. Notice of Proposed Rulemaking, Notice of Termination, 67 FR 77951, 77953 (December 20, 2002). No one submitted comments in opposition to the proposed regulation, and the requirement was subsequently adopted in interim and final regulations.<E T="03">See</E>Interim Rule, Notice of Termination, 67 FR 78176 (December 23, 2002) and Final Regulation, Notice of Termination, 68 FR 16958 (April 8, 2003). This history notwithstanding, the Copyright Office does recognize that terminations effected under section 203 are only now ripe, meaning that they are possible for the first time as of January 1, 2013. This is not to say notices could not be filed sooner. Indeed, for grants entered into thirty-five years ago, during 1978, they could first be filed as of 2003, as early as 10 years prior to the earliest possible effective date. But we do allow for the fact that stakeholders are now focused on the issue to an increasing degree, as the actual effective dates for section 203 begin to loom.</P>

        <P>The Copyright Office also wishes to underscore that the existing regulations, and the regulation adopted today, do not provide that a notice of termination should identify the date of creation of the work. Rather, the regulation requires identification of the date of execution of the grant because for purposes of section 203, the date of execution is central to establishing the 5-year window, 35-40 years later, during which termination is permissible and may be effected. But, as noted above and in the Office's more extensive<E T="03">Analysis of Gap Grants Under the Termination Provisions of Title 17,</E>the purpose of the regulation being adopted today is to permit recordation of a notice of termination of a Gap Grant when the terminating party recites, as the date of execution of the grant, the date the work was created. The notice of termination need not expressly recite that the work was created on a particular date (although it may do so). However, for purposes of establishing timeliness, it seems prudent, if not essential, that the notice recite a date of execution of the grant. This said, and as stated above, the Office is not unwilling to consider the issue more fully in a separate proceeding, which could address questions including whether current regulatory authority would allow the Office to publish practical solutions or alternatives to documenting the date of execution, for the sake of providing guidance to authors and grantees alike and for the sake of establishing clarity in the marketplace.</P>

        <P>The Office also believes the existing regulations on notices of termination offer some relief to terminating parties when they cannot precisely identify the date the work was created. Section 201.10 has, since it was first adopted in 1977, included a “harmless error” provision. That provision currently provides that “errors made in giving the date or registration number referred to in paragraph (b)(1)(iii), (b)(2)(iii), or (b)(2)(iv) of this section * * * shall not affect the validity of the notice if the errors were made in good faith and without any intention to deceive, mislead, or conceal relevant information.” 37 CFR 201.10(e)(2). Thus, since 1977 harmless errors in identifying “the date copyright was originally secured i[n] each work to which the notice of termination applies,” the requirement set forth in paragraph (b)(1)(iii), have not affected the validity of the notice. More pertinently, harmless errors in reciting the date of execution, the requirement set forth in paragraph (b)(2)(iii) of section 201.10, also have not affected the validity of a notice of termination under section 203 since regulations governing section 203 notices of termination were first adopted. This provision should provide relief for terminating parties who provide a date of execution which, although it is as accurate as the terminating party is able to ascertain, turns out not to be the actual date of execution of the grant (<E T="03">i.e.,</E>in the case of a Gap Grant, the actual date the work was created), so long as the date is provided in good faith and without any intention to deceive, mislead or conceal relevant information.</P>
        <P>Of course, if the wrong date is recited in the notice and a court subsequently determines that the actual date of execution was at a time that places the effective date of termination or the date of service of the notice of termination outside of the statutory windows, the harmless error doctrine will be of no assistance. But that would not be the result of the misstatement in the notice of termination of the date of execution; rather, it would be because upon a review of all the relevant facts, a court concludes that the actual date of execution was too early or too late to provide a basis for the service of the notice of termination.</P>

        <P>With respect to the specific regulatory text proposed in the notice of proposed rulemaking, the RIAA's comment has persuaded the Copyright Office that treating the identification of the date of execution as a matter of “timeliness” is the wrong approach because it conflates two different topics: (1) Whether a notice of termination was served and/or submitted for recordation on time, and (2) whether the grant that is the subject of the notice of termination was made at a time that qualifies it for termination under section 203. The analysis of the first topic assumes that the grant is terminable under section 203; it simply examines whether the notice was served and recorded in the permissible time frame. In contrast, the analysis of the second topic addresses the very<PRTPAGE P="32320"/>eligibility of the grant for termination under section 203.</P>
        <P>Moreover, as originally drafted, the proposed amendments to § 201.10(f)(4) related only to section 203 notices of termination, even though § 201.10(f)(4) in fact covers both section 203 and section 304 notices of termination. In particular, the following passage ignored the fact that paragraph 4 is supposed to cover both types of termination:</P>
        
        <EXTRACT>
          <P>Conditions under which a notice of termination will be considered untimely include: The date of execution stated therein does not fall on or after January 1, 1978, as required by section 203(a) of title 17, United States Code; the effective date of termination does not fall within the five-year period described in section 203(a)(3) of title 17, United States Code.</P>
        </EXTRACT>
        
        <P>The Office has therefore concluded that the language relating to identification of the date of execution of the grant should not be included in § 201.10(f)(4), but should be moved to a separate paragraph (f)(5) addressing only the issue of date of execution. The other proposed revisions to § 201.10(f)(4), describing situations in which a notice of termination will be considered untimely, should remain but should be amplified by a reference to section 304(c)(3) (which, like section 203(a)(3), requires that the effective date of termination fall within a prescribed time frame) following the language that currently addresses situations in which the effective date of termination does not fall within the five-year period specified by section 203(a)(3). As a result, the second sentence of § 201.10(f)(4) shall read as follows: “Conditions under which a notice of termination will be considered untimely include: The effective date of termination does not fall within the five-year period described in section 203(a)(3) or section 304(c)(3), as applicable, of title 17, United States Code; or the documents submitted indicate that the notice of termination was served less than two or more than ten years before the effective date of termination.” As noted in the notice of proposed rulemaking, the circumstances identified in this paragraph (b)(4) are not intended to be an exhaustive list of procedural failures that may result in failure to record notices of termination.</P>
        <P>For the sake of clarity, the new paragraph addressing identification of the date of execution shall also specifically address the issue of Gap Grants:</P>
        
        <EXTRACT>
          <P>(5) In any case where an author agreed, prior to January 1, 1978, to make a grant of a transfer or license of rights in a work that was not created until on or after January 1, 1978, a notice of termination of a grant under section 203 of title 17 may be recorded if it recites, as the date of execution, the date on which the work was created.</P>
        </EXTRACT>
        
        <P>The sole remaining issue is whether, as SIIA suggested, additional language is necessary to clarify that this regulation is not a “merits-based determination that could be incorrectly used by authors as authority for the applicability of section 203 of Title 17.” As stated in the notice of proposed rulemaking, the Office's recordation of notices of termination of Gap Grants is without prejudice to how a court might ultimately rule on whether any particular document qualifies as a notice of termination within the scope of section 203, consistent with longstanding practices for all notices of termination recorded by the Office. By permitting recordation of such a notice of termination, the Office permits the terminating party to move forward based upon a reasonable interpretation of the statute. Refusing to permit recordation of a notice of termination of a Gap Grant would put the Office in the position of imposing an unjustified impediment to the ability of an author or an author's heirs to assert what may well be a viable right to terminate a grant. If there is any dispute over the validity of such a notice of termination (or of notices of termination of Gap Grants in general), that dispute should be settled in the courts (or in Congress, if Congress accepts the Office's suggestion to enact legislation that will clarify the status of Gap Grants).</P>
        <P>The amendment proposed in the notice of proposed rulemaking included, in § 201.10(f)(4), the already-existing language that “Whether a document so recorded is sufficient in any instance to effect termination as a matter of law shall be determined by a court of competent jurisdiction.” However, that language would no longer apply to recordation of Gap Grants now that the language relating to Gap Grants is being expanded and moved to a separate paragraph. In considering the issue further, the Office concludes that the proposed language is no longer necessary in § 201.10(f)(4) because the existing regulatory text in § 201.10(f)(5) (which will be renumbered as § 201.10(f)(6) following the insertion of the new paragraph (f)(5)) makes it clear that recordation of a notice of termination does not mean that the notice meets the requirements of the law:</P>
        
        <EXTRACT>
          <P>“A copy of the notice of termination shall be recorded in the Copyright Office before the effective date of termination, as a condition to its taking effect. However, the fact that the Office has recorded the notice does not mean that it is otherwise sufficient under the law. Recordation of a notice of termination by the Copyright Office is without prejudice to any party claiming that the legal and formal requirements for issuing a valid notice have not been met.”</P>
        </EXTRACT>
        
        <P>However, we have modified that paragraph to include a reference to “a court of competent jurisdiction,” as this phrase appears in the existing language in paragraph (f)(4) and was included in the notice of proposed rulemaking.</P>
        <LSTSUB>
          <HD SOURCE="HED">List of Subjects in 37 CFR Part 201</HD>
          <P>Copyright, General provisions.</P>
        </LSTSUB>
        <HD SOURCE="HD1">Final Regulation</HD>
        <P>In consideration of the foregoing, the Copyright Office amends part 201 of 37 CFR, as follows:</P>
        <REGTEXT PART="201" TITLE="37">
          <PART>
            <HD SOURCE="HED">PART 201—GENERAL PROVISIONS</HD>
          </PART>
          <AMDPAR>1. The authority citation for part 201 continues to read as follows:</AMDPAR>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>17 U.S.C. 702; section 201.10 also issued under 17 U.S.C. 203 and 304.</P>
          </AUTH>
        </REGTEXT>
        <REGTEXT PART="201" TITLE="37">
          <AMDPAR>2. Section 201.10 is amended as follows:</AMDPAR>
          <AMDPAR>a. By revising paragraph (f)(4);</AMDPAR>
          <AMDPAR>b. By redesignating paragraphs (f)(5) and (f)(6) as paragraphs (f)(6) and (f)(7);</AMDPAR>
          <AMDPAR>c. By adding a new paragraph (f)(5);</AMDPAR>
          <AMDPAR>d. In redesignated paragraph (f)(6), by removing “met.” and adding in its place “met, including before a court of competent jurisdiction.”</AMDPAR>
          <SECTION>
            <SECTNO>§ 201.10</SECTNO>
            <SUBJECT>Notices of termination of transfers and licenses.</SUBJECT>
            <STARS/>
            <P>(f) * * *</P>

            <P>(4) Notwithstanding anything to the contrary in this section, the Copyright Office reserves the right to refuse recordation of a notice of termination as such if, in the judgment of the Copyright Office, such notice of termination is untimely. Conditions under which a notice of termination will be considered untimely include: the effective date of termination does not fall within the five-year period described in section 203(a)(3) or section 304(c)(3), as applicable, of title 17, United States Code; or the documents submitted indicate that the notice of termination was served less than two or more than ten years before the effective date of termination. If a notice of termination is untimely or if a document is submitted for recordation as a notice of termination on or after the effective date of termination, the Office will offer to record the document as a “document pertaining to copyright” pursuant to § 201.4(c)(3), but the Office will not index the document as a notice of termination.<PRTPAGE P="32321"/>
            </P>
            <P>(5) In any case where an author agreed, prior to January 1, 1978, to a grant of a transfer or license of rights in a work that was not created until on or after January 1, 1978, a notice of termination of a grant under section 203 of title 17 may be recorded if it recites, as the date of execution, the date on which the work was created.</P>
            <STARS/>
          </SECTION>
        </REGTEXT>
        <SIG>
          <DATED>Dated: May 27, 2011.</DATED>
          <NAME>Maria A. Pallante,</NAME>
          <TITLE>Acting Register of Copyrights.</TITLE>
          
          <FP>Approved by</FP>
          <NAME>James H. Billington,</NAME>
          <TITLE>The Librarian of Congress.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13845 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 1410-30-P</BILCOD>
    </RULE>
    <RULE>
      <PREAMB>
        <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
        <CFR>40 CFR Part 52</CFR>
        <DEPDOC>[EPA-R03-OAR-2011-0379; FRL-9314-4]</DEPDOC>
        <SUBJECT>Approval and Promulgation of Air Quality Implementation Plans;Pennsylvania; Revision to the Inspection and Maintenance (I/M) Program—Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Environmental Protection Agency (EPA).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Direct final rule.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>EPA is taking direct final action to approve revisions to the Pennsylvania State Implementation Plan (SIP). The revision consists of a change by the Commonwealth of Pennsylvania to the quality assurance program for its motor vehicle inspection and maintenance program (I/M program). Specifically, the Commonwealth is amending a provision of its prior SIP-approved I/M program to change the duration of the timing of quality assurance audits performed by the Pennsylvania Department of Transportation (PENNDOT) as part of their program oversight. The amendment allows for these audits to be conducted within five days of vehicle inspection, instead of the two-day window allowed under the prior approved SIP. This SIP revision affects forty-two counties in Pennsylvania where visual emissions equipment inspections are performed as part of the Commonwealth's annual vehicle safety inspection program (<E T="03">i.e.,</E>non-I/M counties). It does not affect the twenty-five counties where separate enhanced I/M emissions inspections are performed in addition to the annual safety inspection program (<E T="03">i.e.,</E>I/M counties). This SIP revision applies to PENNDOT staff overseeing stations that conduct safety inspections in non-I/M program counties. It does not impact motorists subject to the program or stations that perform emissions inspections. EPA is approving this amendment to Pennsylvania's approved I/M SIP in accordance with the requirements of the Clean Air Act (CAA).</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>

          <P>This rule is effective on August 5, 2011 without further notice, unless EPA receives adverse written comment by July 6, 2011. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the<E T="04">Federal Register</E>and inform the public that the rule will not take effect.</P>
        </EFFDATE>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit your comments, identified by Docket ID Number EPA-R03-OAR-2011-0379 by one of the following methods:</P>
          <P>A.<E T="03">http://www.regulations.gov.</E>Follow the on-line instructions for submitting comments.</P>
          <P>B.<E T="03">E-mail: fernandez.cristina@epa.gov.</E>
          </P>
          <P>C.<E T="03">Mail:</E>EPA-R03-OAR-2011-0379, Cristina Fernandez, Associate Director, Office of Air Program Planning, Mailcode 3AP30, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.</P>
          <P>D.<E T="03">Hand Delivery:</E>At the previously-listed EPA Region III address. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.</P>
          <P>
            <E T="03">Instructions:</E>Direct your comments to Docket ID No. EPA-R03-OAR-2011-0379. EPA's policy is that all comments received will be included in the public docket without change, and may be made available online at<E T="03">http://www.regulations.gov,</E>including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through<E T="03">http://www.regulations.gov</E>or e-mail. The<E T="03">http://www.regulations.gov</E>Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through<E T="03">http://www.regulations.gov,</E>your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.</P>
          <P>
            <E T="03">Docket:</E>All documents in the electronic docket are listed in the<E T="03">http://www.regulations.gov</E>index. Although listed in the index, some information is not publicly available,<E T="03">i.e.,</E>CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in<E T="03">http://www.regulations.gov</E>or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.</P>
          <P>Copies of the State submittal are available at the Pennsylvania Department of Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market Street, Harrisburg, Pennsylvania 17105.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Brian Rehn, (215) 814-2176, or by e-mail at<E T="03">rehn.brian@epa.gov</E>.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>Throughout this document, whenever “we,” “us,” or “our” is used, we mean EPA.</P>
        <HD SOURCE="HD1">I. Background</HD>

        <P>On May 22, 2009, the Commonwealth of Pennsylvania submitted a formal revision to its SIP. That SIP revision, which is the subject of this action, consists of an amendment to the enhanced motor vehicle emission inspection program SIP submitted by Pennsylvania on December 1, 2003 and approved as part of the Commonwealth's SIP on October 6, 2005 (70 FR 58313). This SIP revision amends Pennsylvania's quality assurance program, which applies to PENNDOT staff that oversee the anti-tampering visual inspection performed as part of the annual safety inspection program in the forty-two Pennsylvania<PRTPAGE P="32322"/>counties (where separate enhanced I/M inspection is not required).</P>
        <HD SOURCE="HD1">II. Summary of SIP Revision</HD>
        <P>Pennsylvania's approved I/M SIP includes, as a SIP-strengthening measure, a program to address emissions from in-use vehicles registered in counties in Pennsylvania that are not mandated by the CAA to have an emission inspection program. In these forty-two non-I/M counties, Pennsylvania requires (as part of its annual vehicle safety inspection) a visual check of select vehicle emission components to ensure that the components have not been removed or disconnected, and that they are the correctly configured components for that particular vehicle (referred to hereafter as the anti-tampering program). This SIP-approved anti-tampering program check applies to the following components (where equipped on a new vehicle as part of an EPA-certified configuration): Catalytic converter, exhaust gas recirculation (EGR) valve, positive crankcase ventilation (PCV) valve, fuel inlet restrictor, air pump, and evaporative control system. The non-I/M region affected by this SIP revision is comprised of the following counties: Adams, Armstrong, Bedford, Bradford, Butler, Cameron, Carbon, Clarion, Clearfield, Clinton, Columbia, Crawford, Elk, Fayette, Forest, Franklin, Fulton, Greene, Huntingdon, Indiana, Jefferson, Juniata, Lawrence, McKean, Mifflin, Monroe, Montour, Northumberland, Perry, Pike, Potter, Schuylkill, Snyder, Somerset, Sullivan, Susquehanna, Tioga, Union, Venango, Warren, Wayne, and Wyoming.</P>
        <P>The SIP revision amends a portion of the Commonwealth's quality assurance program for safety inspections, as it relates to administrative audits of approximately 5,200 safety inspection stations in the forty-two non-I/M counties. The quality assurance program established a window during which program auditors ascertain whether selected vehicles properly passed the required visual emissions equipment inspection portion of the state-required, annual vehicle safety inspection. After reviewing its procedures, PENNDOT determined that increasing the length of time between the safety inspection and the allowable time by when PENNDOT inspectors can perform an inspection audit from two to five days allows for improved oversight of the visual inspection portion of the safety inspection program. This allows the Commonwealth to better assure that the visual inspection is being properly performed as part of the safety inspection in non-I/M counties, ensuring that these emission components are present and have not been tampered with, as is required by the CAA. The visual inspection bolsters the Commonwealth's SIP by ensuring that vehicles in non-I/M counties in the Commonwealth are operated with the required emissions components in place. The Commonwealth's SIP revision is intended to improve the Commonwealth's ability to oversee the safety inspection program in the non-I/M counties to better ensure that the visual emissions component inspection is being properly performed by safety inspection technicians. This SIP revision is a procedural change that does not affect the Commonwealth's prior SIP-approved I/M regulations, nor does it affect oversight of the I/M program in the 25 counties where I/M is performed separately from the state safety inspection program.</P>
        <HD SOURCE="HD1">III. Final Action</HD>

        <P>EPA is approving Pennsylvania's SIP revision to amend the quality assurance program for visual emission component inspection performed as part of the Commonwealth's annual safety inspection program in non-I/M counties. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's<E T="04">Federal Register</E>, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on August 5, 2011 without further notice unless EPA receives adverse comment by July 6, 2011. If EPA receives adverse comment, EPA will publish a timely withdrawal in the<E T="04">Federal Register</E>informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.</P>
        <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
        <HD SOURCE="HD2">A. General Requirements</HD>
        <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:</P>
        <P>• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);</P>

        <P>• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501<E T="03">et seq.</E>);</P>

        <P>• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601<E T="03">et seq.</E>);</P>
        <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);</P>
        <P>• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
        <P>• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);</P>
        <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);</P>
        <P>• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and</P>
        <P>• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).</P>
        
        <FP>In addition, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on Tribal governments or preempt Tribal law.</FP>
        <HD SOURCE="HD2">B. Submission to Congress and the Comptroller General</HD>
        <P>The Congressional Review Act, 5 U.S.C. 801<E T="03">et seq.,</E>as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General<PRTPAGE P="32323"/>of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the<E T="04">Federal Register</E>. A major rule cannot take effect until 60 days after it is published in the<E T="04">Federal Register</E>. This action is not a “major rule” as defined by 5 U.S.C. 804(2).</P>
        <HD SOURCE="HD2">C. Petitions for Judicial Review</HD>

        <P>Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 5, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's<E T="04">Federal Register</E>, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking.</P>
        <P>This action to approve Pennsylvania's quality assurance program changes for oversight of the safety inspection program in non-I/M counties may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)</P>
        <LSTSUB>
          <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
          <P>Environmental protection, Air pollution control, Carbon monoxide, Environmental protection, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Volatile organic compounds.</P>
        </LSTSUB>
        <SIG>
          <DATED>Dated: May 18, 2011.</DATED>
          <NAME>Shawn M. Garvin,</NAME>
          <TITLE>Regional Administrator, Region III.</TITLE>
        </SIG>
        
        <P>40 CFR part 52 is amended as follows:</P>
        <REGTEXT PART="52" TITLE="40">
          <PART>
            <HD SOURCE="HED">PART 52—[AMENDED]</HD>
          </PART>
          <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>42 U.S.C. 7401<E T="03">et seq.</E>
            </P>
          </AUTH>
        </REGTEXT>
        <REGTEXT PART="52" TITLE="40">
          <SUBPART>
            <HD SOURCE="HED">Subpart NN—Pennsylvania</HD>
          </SUBPART>
          <AMDPAR>2. In § 52.2020, the table in paragraph (e)(1) is amended by adding an entry for Revision of the Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties at the end of the table to read as follows:</AMDPAR>
          <SECTION>
            <SECTNO>§ 52.2020</SECTNO>
            <SUBJECT>Identification of plan.</SUBJECT>
            <STARS/>
            <P>(e) * * *</P>
            <P>(1) * * *</P>
            <GPOTABLE CDEF="s50,r150,10,r50,r50" COLS="5" OPTS="L1,tp0,i1">
              <TTITLE/>
              <BOXHD>
                <CHED H="1">Name of non-regulatory SIP revision</CHED>
                <CHED H="1">Applicable geographic area</CHED>
                <CHED H="1">State submittal date</CHED>
                <CHED H="1">EPA approval date</CHED>
                <CHED H="1">Additional<LI>explanation</LI>
                </CHED>
              </BOXHD>
              <ROW>
                <ENT I="22"/>
              </ROW>
              <ROW>
                <ENT I="28">*******</ENT>
              </ROW>
              <ROW>
                <ENT I="01">Revision of the Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties</ENT>
                <ENT>Non-I/M Program Region, Counties of: Adams, Armstrong, Bedford, Bradford, Butler, Cameron, Carbon, Clarion, Clearfield, Clinton, Columbia, Crawford, Elk, Fayette, Forest, Franklin, Fulton, Greene, Huntingdon, Indiana, Jefferson, Juniata, Lawrence, McKean, Mifflin, Monroe, Montour, Northumberland, Perry, Pike, Potter, Schuylkill, Snyder, Somerset, Sullivan, Susquehanna, Tioga, Union, Venango, Warren, Wayne, and Wyoming</ENT>
                <ENT>5/22/09</ENT>
                <ENT>6/6/11 [Insert page number where the document begins]</ENT>
                <ENT>Applicable to SIP-approved safety inspection program regulation for non-I/M counties at Title 67, Part 1, Chapter 175.</ENT>
              </ROW>
            </GPOTABLE>
            <STARS/>
          </SECTION>
        </REGTEXT>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13878 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6560-50-P</BILCOD>
    </RULE>
    <RULE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Coast Guard</SUBAGY>
        <CFR>46 CFR Part 45</CFR>
        <DEPDOC>[Docket No. USCG-1998-4623]</DEPDOC>
        <RIN>RIN 1625-AA17</RIN>
        <SUBJECT>Limited Service Domestic Voyage Load Lines for River Barges on Lake Michigan</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Coast Guard, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Final rule.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Coast Guard is amending the special load line exemption regime for certain river barges operating on Lake Michigan, as established in the final rule published on November 18, 2010. Specifically, the weather restrictions based on Small Craft Advisory conditions are being replaced with the original weather restrictions implemented in 2002 by an interim rule.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>This final rule is effective on June 15, 2011.</P>
        </EFFDATE>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>Comments and material received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-1998-4623 and are available for inspection or copying at the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to<E T="03">http://www.regulations.gov,</E>inserting USCG-1998-4623 in the “Keyword” box, and then clicking “Search.”</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>If you have questions on this rule, call or e-mail Mr. Thomas Jordan, Office of Design and Engineering Standards, Naval Architecture Division (CG-5212), Coast Guard; telephone 202-372-1370, e-mail<E T="03">Thomas.D.Jordan@uscg.mil.</E>If you have questions on viewing or submitting material to the docket, call Ms. Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>
        <HD SOURCE="HD1">Table of Contents for Preamble</HD>
        <EXTRACT>
          <FP SOURCE="FP-2">I. Abbreviations</FP>
          <FP SOURCE="FP-2">II. Regulatory History</FP>
          <FP SOURCE="FP-2">III. Basis and Purpose</FP>
          <FP SOURCE="FP-2">IV. Background</FP>
          <FP SOURCE="FP-2">V. Discussion of Comments and Changes</FP>
          <FP SOURCE="FP1-2">A. Discussion of Public Comments</FP>
          <FP SOURCE="FP1-2">B. Discussion of Changes</FP>
          <FP SOURCE="FP-2">VI. Regulatory Analyses</FP>
          <FP SOURCE="FP1-2">A. Executive Order 12866 and Executive Order 13563</FP>
          <FP SOURCE="FP1-2">B. Small Entities</FP>
          <FP SOURCE="FP1-2">C. Assistance for Small Entities</FP>
          <FP SOURCE="FP1-2">D. Collection of Information</FP>
          <FP SOURCE="FP1-2">E. Federalism</FP>
          <FP SOURCE="FP1-2">F. Unfunded Mandates Reform Act</FP>
          <FP SOURCE="FP1-2">G. Taking of Private Property</FP>
          <FP SOURCE="FP1-2">H. Civil Justice Reform</FP>
          <FP SOURCE="FP1-2">I. Protection of Children</FP>
          <FP SOURCE="FP1-2">J. Indian Tribal Governments</FP>
          <FP SOURCE="FP1-2">K. Energy Effects<PRTPAGE P="32324"/>
          </FP>
          <FP SOURCE="FP1-2">L. Technical Standards</FP>
          <FP SOURCE="FP1-2">M. Environment</FP>
        </EXTRACT>
        <HD SOURCE="HD1">I. Abbreviations</HD>
        <EXTRACT>
          <FP SOURCE="FP-1">ABSAmerican Bureau of Shipping</FP>
          <FP SOURCE="FP-1">DHSDepartment of Homeland Security</FP>
          <FP SOURCE="FP-1">HazMatHazardous Material</FP>
          <FP SOURCE="FP-1">NEPANational Environmental Policy Act of 1969</FP>
          <FP SOURCE="FP-1">SCASmall Craft Advisory</FP>
        </EXTRACT>
        <HD SOURCE="HD1">II. Regulatory History</HD>

        <P>On November 18, 2010, the Coast Guard published a final rule in the<E T="04">Federal Register</E>(75 FR 70595) (2010 final rule) that finalized the special Lake Michigan load line regime that had been in effect under an interim rule since 2002. The history of this rulemaking, from the initial request by the Port of Milwaukee in 1991 through the publishing of the final rule in 2010, is recounted in the 2010 final rule.</P>
        <P>The 2010 final rule revised and clarified some of the interim rule provisions, including substitution of Small Craft Advisory (SCA) conditions as the limiting weather restrictions in place of a variety of weather conditions used under the interim rule.</P>

        <P>Subsequent to publishing the 2010 final rule (and before its effective date), we published a notice of delay in the<E T="04">Federal Register</E>(75 FR 78928) on December 17, 2010. This notice was prompted by comments from some operators that the use of SCA conditions as the limiting weather restriction would adversely impact barge movements on the Burns Harbor route. To adequately review this issue, we published the notice of delay, which suspended the effective date of the SCA weather restrictions for 6 months. The notice further explained our rationale for using SCA conditions, opened a 30-day comment period, and requested public comment specifically on the issue of weather restrictions. During the delay period, the weather restrictions established in the interim rule remained in effect, but all other provisions in the final rule entered into effect on December 20, 2010, as published.</P>

        <P>Under 5 U.S.C. 553(d)(1), the Coast Guard is making this rule effective less than 30 days after publication in the<E T="04">Federal Register</E>because the rule relieves the restriction of Small Craft Advisories as the limiting weather restrictions for participation in this regime.</P>
        <HD SOURCE="HD1">III. Basis and Purpose</HD>
        <P>The purpose of this current action is to amend the weather restrictions in 46 CFR 45.171 (Table 45.171), 45.187, and 45.191, as published in the 2010 final rule.</P>
        <P>This action is in accordance with 46 U.S.C. 5104(e), which authorizes the Secretary to establish load line regulations for specific geographic areas, taking into account weather and sea conditions, and availability of safe refuge (this authority has been delegated to the Coast Guard per DHS delegation 0170.1).</P>
        <HD SOURCE="HD1">IV. Background</HD>
        <P>This final rule narrowly pertains to the weather restrictions for certain dry cargo river barges operating on Lake Michigan under a special load line regime. Such restrictions are necessary because river barge hull construction is not robust enough for safe unrestricted operation on the Great Lakes. The regime was established under an interim rule in 2002, which prescribed a variety of limiting weather conditions based on route, wind speed and direction, wave heights, and ice conditions, among other factors. As we explained in the notice of delay, we subsequently identified SCA conditions as issued by the National Weather Service Nearshore Marine Forecasts for Lake Michigan as being an equivalent basis for weather restrictions. We believed that the substitution of SCA-based restrictions in the final rule would offer the benefit of simplifying and clarifying the weather restrictions without adversely affecting the level of operations or reducing the level of safety.</P>
        <P>However, several towing vessel operators expressed their concerns that the SCA conditions were overly restrictive compared to the original weather restrictions in the interim rule, and would reduce the number of operational days for moving barges, especially on the Burns Harbor route. In order to adequately review these concerns, we delayed the effective date of the SCA weather restrictions for 6 months and solicited public comments, on the issue of weather restrictions.</P>
        <HD SOURCE="HD1">V. Discussion of Comments and Changes</HD>
        <HD SOURCE="HD2">A. Discussion of Public Comments</HD>
        <P>The notice of delay specifically requested public comment on the issue of weather restrictions. In response, we received 23 comments. The commenters included barge or towboat operators and towboat captains, as well as terminal operators, marine operator associations, and some local businesses. All of the commenters urged reconsideration of the SCA limitation and/or restoration of the previous weather limitations under the interim rule. The comments are categorized and discussed below.</P>
        <P>
          <E T="03">Effect on towing operations:</E>Commenters pointed out that the Nearshore Marine Forecasts conservatively assume that wave conditions are the same all across the forecast corridor (<E T="03">i.e.,</E>from shoreline to 5 miles out). However, the commenters noted that even under nominal SCA conditions with high winds, if the wind direction is favorable (<E T="03">i.e.,</E>southerly or south-westerly on the Burns Harbor route), wave conditions close to shore are still benign even though higher waves develop just a few miles further offshore. Under such high offshore wind conditions, the towboat practice is to stay within approximately 1 mile of the shoreline, a strategy that some of the commenters referred to as “beachcombing.” Two commenters specifically cited personal observations of wave conditions on dates when SCAs had been issued but nearshore conditions were calm enough for tows to safely transit. Some commenters pointed out the relatively short 21-mile distance between Calumet Harbor and Burns Harbor (approximately 3 hours transit) with two ports of refuge along the way, and noted that movements along that route can take place under favorable short-term weather conditions. The commenters stated that “no sail” restrictions under SCA conditions would unnecessarily prevent them from moving barges under safe conditions. The commenters further stated that sailing decisions are best made by experienced towboat captains on the water, observing conditions directly. They supported this position by claiming that making such decisions using the captain's discretion has been towboat practice for several decades, and that thousands of barges have been moved without weather-related casualties.</P>

        <P>The Coast Guard's governing safety issue is to ensure that wave conditions do not overstress river barge hulls. Small Craft Advisories are issued taking into consideration various factors expected during the forecast period, including wave heights. However, we recognize that wave conditions within the 5-mile-wide nearshore forecast zone can vary significantly depending on wind direction, and that acceptable wave conditions can be found closer to shore even when higher waves might be forecasted. We further recognize the long-term safety record of the towboat operators under the previous “fair weather” restrictions (that have been in effect under a previous rulemaking since 1985), and agree that experienced towboat captains can make safe sailing decisions based on actual weather<PRTPAGE P="32325"/>conditions for the duration of the voyage. For this reason, we have amended the weather restrictions in 46 CFR 45.171 (Table 45.171), 45.187, and 45.191.</P>
        <P>
          <E T="03">Effect on other commercial operations:</E>All commenters discussed the adverse impact of reduced barge movements on local marine terminals, warehouses, and other businesses that rely upon cargo delivered by river barges. The comments variously contended that SCA restrictions would result in delayed shipments, lost production time, and higher costs.</P>
        <P>Although the comments did not include specific figures on cost and production, we recognize that reduced barge movements, especially on the Burns Harbor route, could have an adverse impact. To the extent that safety is not compromised, we do not intend to unnecessarily restrict barge operations on the Lake. For this reason, we have amended the weather restrictions in 46 CFR 45.171 (Table 45.171), 45.187, and 45.191.</P>
        <P>
          <E T="03">Other comments:</E>Several comments discussed the potential shift of cargo movements to alternate transportation modes, such as trucks and railroads. The comments contended that such a shift would lead to increased highway traffic and higher transportation costs for shippers and customers, and that barge transport is environmentally friendly, as it produces fewer emissions per ton-mile.</P>
        <P>We recognize the economic and environmental efficiency of barge transportation of the products and materials carried under this special load line regime and, as stated above, we do not intend to unnecessarily restrict current barge operations. For this reason, we have amended the weather restrictions in 46 CFR 45.171 (Table 45.171), 45.187, and 45.191.</P>
        <HD SOURCE="HD2">B. Discussion of Changes</HD>

        <P>After more than 8 years, the level of safety established by the weather restrictions in the interim rule has proven to be acceptable. Therefore, upon consideration of this record and the public comments, we have decided to restore the original weather limits established under the interim rule. Accordingly, we make the following changes to the final rule published in the<E T="04">Federal Register</E>(75 FR 70595) on November 18, 2010:</P>
        <P>
          <E T="03">§ 45.171Purpose:</E>In paragraph (c), we revise Table 45.171 to restore the original weather restrictions that appeared in the interim rule.</P>
        <P>
          <E T="03">§ 45.187Weather limitations:</E>We remove all references to SCA conditions. In paragraph (a), we restore the original “fair weather conditions” for the Burns Harbor route. In paragraph (b), we restore the original reference to Table 45.171 for the Milwaukee, St. Joseph, and Muskegon routes. We restore paragraph (c) to the original wording that appeared in the interim rule.</P>
        <P>
          <E T="03">§ 45.191Pre-departure preparations:</E>In paragraph (a), we remove a reference to the SCA and restore the original wording that appeared in the interim rule.</P>
        <HD SOURCE="HD1">VI. Regulatory Analyses</HD>
        <P>We developed this final rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.</P>
        <HD SOURCE="HD2">A. Executive Order 12866 and Executive Order 13563</HD>
        <P>This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review. This final rule does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866. The Office of Management and Budget has not reviewed it under these Orders.</P>
        <P>The purpose of this final rule is to avoid unnecessary disruptions to barge owners and operators by restoring the original weather restrictions, in 46 CFR 45.171, under which the industry has operated river barges on the Lake Michigan routes since 2002, as established in the interim rule (67 FR 19685). Based on public comments, this rule deletes the SCA weather restrictions in the final rule, published November 18, 2010. The restoration of the weather restrictions under the 2002 interim rule will allow owners and operators on Lake Michigan routes to retain the flexibility to move barges and cargo under the original weather criteria in Table 45.171. All other provisions of the published final rule are effective as of December 20, 2010.</P>
        <HD SOURCE="HD2">B. Small Entities</HD>
        <P>Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.</P>
        <P>The removal of the SCA weather restrictions will allow small entities the flexibility to move barges on the affected routes using the original weather conditions that were established by the interim rule in 2002. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.</P>
        <HD SOURCE="HD2">C. Assistance for Small Entities</HD>
        <P>Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.</P>
        <P>Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).</P>
        <HD SOURCE="HD2">D. Collection of Information</HD>
        <P>This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We received no additional information to alter the existing collection of information.</P>
        <HD SOURCE="HD2">E. Federalism</HD>

        <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. It is well settled that States may not regulate in categories reserved for regulation by the Coast Guard. It is also well settled, now, that all of the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101 (design, construction, alteration, repair, maintenance, operation, equipping, personnel qualification, and manning of vessels), as well as the reporting of casualties and any other category in which Congress intended the Coast Guard to be the sole source of a vessel's obligations, are within the field<PRTPAGE P="32326"/>foreclosed from regulation by the States. (See the decision of the Supreme Court in the consolidated cases of<E T="03">United States</E>v.<E T="03">Locke</E>and<E T="03">Intertanko</E>v.<E T="03">Locke,</E>529 U.S. 89, 120 S.Ct. 1135 (March 6, 2000).)</P>
        <P>This final rule concerns load line assignments for vessels under U.S. jurisdiction. This is a category in which Congress intended the Coast Guard to be the sole source of a vessel's obligations. Because the States may not regulate within this category, preemption under Executive Order 13132 is not an issue.</P>
        <HD SOURCE="HD2">F. Unfunded Mandates Reform Act</HD>
        <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this final rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.</P>
        <HD SOURCE="HD2">G. Taking of Private Property</HD>
        <P>This final rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.</P>
        <HD SOURCE="HD2">H. Civil Justice Reform</HD>
        <P>This final rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.</P>
        <HD SOURCE="HD2">I. Protection of Children</HD>
        <P>We have analyzed this final rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This final rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.</P>
        <HD SOURCE="HD2">J. Indian Tribal Governments</HD>
        <P>This final rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.</P>
        <HD SOURCE="HD2">K. Energy Effects</HD>
        <P>We have analyzed this final rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.</P>
        <HD SOURCE="HD2">L. Technical Standards</HD>

        <P>The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (<E T="03">e.g.,</E>specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.</P>
        <P>This final rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.</P>
        <HD SOURCE="HD2">M. Environment</HD>

        <P>We have analyzed this final rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This final rule is categorically excluded under section 2.B.2, figure 2-1, paragraph (34)(d) of the Instruction and under section 6(a) of the “Appendix to National Environmental Policy Act: Coast Guard Procedures for Categorical Exclusions, Notice of Final Agency Policy” (67 FR 48244, July 23, 2002). Exclusion under paragraph (34)(d) applies because this final rule pertains to regulations concerning inspection of vessels (<E T="03">i.e.,</E>load line requirements). Exclusion under 6(a) of the<E T="04">Federal Register</E>Notice applies because this final rule pertains to regulations concerning vessel operation safety standards. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under<E T="02">ADDRESSES</E>.</P>
        <LSTSUB>
          <HD SOURCE="HED">List of Subjects in 46 CFR Part 45</HD>
          <P>Great Lakes, Reporting and recordkeeping requirements, Vessels.</P>
        </LSTSUB>

        <P>For the reasons discussed in the preamble, the Coast Guard amends 46 CFR part 45, as amended in the final rule published in the<E T="04">Federal Register</E>on November 18, 2010 (75 FR 70595), effective June 15, 2011, as follows:</P>
        <REGTEXT PART="45" TITLE="46">
          <PART>
            <HD SOURCE="HED">PART 45—GREAT LAKES LOAD LINES</HD>
          </PART>
          <AMDPAR>1. The authority citation for part 45 continues to read as follows:</AMDPAR>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>46 U.S.C. 5104, 5108; Department of Homeland Security Delegation No. 0170.1.</P>
          </AUTH>
          
        </REGTEXT>
        <REGTEXT PART="45" TITLE="46">
          <AMDPAR>2. In<E T="03">§ 45.171,</E>revise Table 45.171 in paragraph (c) to read as follows:</AMDPAR>
          <SECTION>
            <SECTNO>§ 45.171</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>
            <STARS/>
            <P>(c) * * *</P>
            <GPH DEEP="452" SPAN="3">
              <PRTPAGE P="32327"/>
              <GID>ER06JN11.055</GID>
            </GPH>
          </SECTION>
        </REGTEXT>
        <REGTEXT PART="45" TITLE="46">
          <AMDPAR>3. Revise § 45.187 to read as follows:</AMDPAR>
          <SECTION>
            <SECTNO>§ 45.187</SECTNO>
            <SUBJECT>Weather limitations.</SUBJECT>
            <P>(a) Tows on the Burns Harbor route must operate during fair weather conditions only.</P>
            <P>(b) The weather limits (ice conditions, wave height, and sustained winds) for the Milwaukee, St. Joseph, and Muskegon routes are specified in § 45.171, Table 45.171.</P>
            <P>(c) If weather conditions are expected to exceed these limits at any time during the voyage, the tow must not leave harbor or, if already underway, must proceed to the nearest appropriate harbor of safe refuge.</P>
          </SECTION>
        </REGTEXT>
        <REGTEXT PART="45" TITLE="46">
          <AMDPAR>4. Revise § 45.191(a) to read as follows:</AMDPAR>
          <SECTION>
            <SECTNO>§ 45.191</SECTNO>
            <SUBJECT>Pre-departure requirements.</SUBJECT>
            <STARS/>
            <P>(a)<E T="03">Weather forecast.</E>Determine the marine weather forecast along the planned route, and contact the dock operator at the destination port to get an update on local weather conditions.</P>
            <STARS/>
          </SECTION>
        </REGTEXT>
        <SIG>
          <DATED>Dated: May 26, 2011.</DATED>
          <NAME>F.J. Sturm,</NAME>
          <TITLE>Acting Director of Commercial Regulations and Standards.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13754 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9110-04-P</BILCOD>
    </RULE>
    <RULE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
        <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
        <CFR>49 CFR Parts 383 and 390</CFR>
        <SUBJECT>Regulatory Guidance on the Designation of Steerable Rear Axle Operators (Tillermen) as Drivers of Commercial Motor Vehicles</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Motor Carrier Safety Administration (FMCSA), DOT.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of Regulatory Guidance.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>FMCSA issues regulatory guidance concerning the applicability of the term “driver” to “tillerman,” a person who controls the steerable rear axle on a commercial motor vehicle. The term “driver” is used in FMCSA's commercial<PRTPAGE P="32328"/>driver's license requirements and in the Agency's general safety rules. This notice provides Federal and State enforcement personnel, and the motor carrier industry, with uniform guidance as to when certain Federal rules concerning driver licensing and qualifications are applicable to tillermen.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>This regulatory guidance is effective June 6, 2011.</P>
        </EFFDATE>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Thomas L. Yager, Chief, Driver and Carrier Operations Division, Office of Bus and Truck Standards and Operations, Federal Motor Carrier Safety Administration, 1200 New Jersey Ave., SE., Washington, DC 20590.<E T="03">E-mail: MCPSD@dot.gov.</E>Phone (202) 366-4325.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">Legal Basis</HD>
        <P>The Motor Carrier Act of 1935 provides that “The Secretary of Transportation may prescribe requirements for (1) qualifications and maximum hours of service of employees of, and safety of operation and equipment of, a motor carrier; and (2) qualifications and maximum hours of service of employees of, and standards of equipment of, a motor private carrier, when needed to promote safety of operation” [49 U.S.C. 31502(b)].</P>
        <P>The Motor Carrier Safety Act of 1984 (MCSA) confers on the Secretary the authority to regulate drivers, motor carriers, and vehicle equipment. It requires the Secretary to prescribe safety standards for commercial motor vehicles (CMVs). At a minimum, the regulations must ensure that (1) CMVs are maintained, equipped, loaded, and operated safely; (2) the responsibilities imposed on operators of CMVs do not impair their ability to operate the vehicles safely; (3) the physical condition of operators of CMVs is adequate to enable them to operate the vehicles safely; and (4) the operation of CMVs does not have a deleterious effect on the physical condition of the operator [49 U.S.C. 31136(a)]. The Act also grants the Secretary broad power to “prescribe recordkeeping and reporting requirements” and to “perform other acts the Secretary considers appropriate” [49 U.S.C. 31133(a)(8) and (10)].</P>
        <P>The Commercial Motor Vehicle Safety Act of 1986 (CMVSA) requires the Secretary to prescribe regulations on minimum licensing and testing standards for persons seeking a commercial driver's license (CDL) to operate a CMV. For purposes of the CMVSA, the term CMV means (among other things) a vehicle with a weight or weight rating of at least 26,001 pounds, compared to a minimum weight threshold of 10,001 pounds for purposes of the MCSA [49 U.S.C. chapter 313].</P>
        <P>The Administrator of FMCSA has been delegated the authority to carry out the functions vested in the Secretary by the Motor Carrier Act of 1935 [49 CFR 1.73(l)], the MCSA [§ 1.73(g)], and the CMVSA [§ 1.73(e)(1)]. The provisions affected by this Notice of Regulatory Guidance are based on these three statutes.</P>
        <HD SOURCE="HD1">Background</HD>
        <P>This document revises current regulatory guidance on the applicability of the definition of a “driver” in 49 CFR 390.5, to “tillerman,” a person exercising control over the movement of a steerable rear axle on a CMV. Section 390.5 states that “Driver means any person who operates any [CMV].” Today's guidance also pertains to CDL requirements for “* * * every person who operates a commercial motor vehicle (CMV) * * *” (§ 383.3(a)).</P>
        <P>Current Regulatory Guidance Question 14 to § 390.5 (62 FR 16370, 16407, April 4, 1997) reads as follows:</P>
        
        <P>“<E T="03">Question 14:</E>Is the tillerman who controls the steerable rear axle of a vehicle so equipped a driver subject to the FMCSRs while operating in interstate commerce?</P>
        <P>
          <E T="03">Guidance:</E>Yes. Although the tillerman does not control the vehicle's speed or braking, the rear-axle steering he/she performs is essential to prevent the trailer from off tracking into other lanes or vehicles or off the highway entirely. Because this function is critical to the safe operation of vehicles with steerable rear axles, the tillerman is a driver.”</P>
        <HD SOURCE="HD1">Reason for This Notice</HD>
        <P>The FMCSA has received inquiries from various entities, including the Professional Escort Vehicle Operators Association and the Specialized Carriers and Riggers Association, asking about other circumstances under which a person exercising control over a CMV's steerable rear axle would be considered a driver of the CMV under § 383.3 and thus subject to the CDL requirements, or a driver under § 390.5 and therefore subject to many provisions of the FMCSRs, such as driver qualifications and hours of service.</P>
        <P>In these new scenarios, the tillerman does not sit on the CMV, but walks alongside it to use a wired or wireless remote control to steer the rear axle; sometimes the tillerman may be in an escort car. These CMVs are typically specialized oversize vehicles on which the rear axle is steered only when “released” and when the CMV is moving at very slow speeds.<SU>1</SU>
          <FTREF/>Under these circumstances, we do not believe that the persons operating the steerable rear axle should be classified as “tillermen,” as the term is used in Question 14. CDL knowledge and skills testing would have little relevance to the remote-control operation of a steerable rear axle on an oversized CMV. Therefore, FMCSA believes it is necessary to update Question 14 for § 390.5 to differentiate among persons who might be considered to be “tillermen,” consistent with the explanation above.</P>
        <FTNT>
          <P>
            <SU>1</SU>Steerable rear axles may have a “locked” or “unlocked” status, used for highway speeds and low speeds, respectively. The status can be changed by operation of the trailer controls when the CMV is not moving. In the “locked” position, the axle may be completely fixed, or have a limited self-steering capability, depending on the manufacturer's design. In the self-steering mode, the axle automatically steers itself within a range determined by the manufacturer to prevent tire scrubbing in turns. Typically, the unlocked mode is used for over-length CMVs that cannot turn at many roadway intersections without steering the rear axle under close guidance of a remote operator.</P>
        </FTNT>
        <P>FMCSA considers the tillerman's physical location in, on, or around a CMV to be the most relevant factor in determining whether the person is a driver. A tillerman physically located on a vehicle is likely to be responsible for steering the rear axles of the CMV at highway speeds, and should be held responsible for safe operation of the vehicle, just like the driver in the cab. Anyone controlling a steerable rear axle from outside the CMV would be doing so under the direction of the person in the cab, and should not be considered a driver. Although certain training may be needed for such remote operators, that would vary according to the equipment involved.</P>
        <P>For the reasons explained above, FMCSA issues Regulatory Guidance Question 34 to § 383.3 and revises Question 14 of the Regulatory Guidance to § 390.5 of the FMCSRs.</P>
        <REGTEXT PART="383" TITLE="49">
          <PART>
            <HD SOURCE="HED">PART 383—COMMERCIAL DRIVERS LICENSE STANDARDS; REQUIREMENTS AND PENALTIES</HD>
            <HD SOURCE="HD2">Section 383.3, “Applicability.”</HD>
            <P>“<E T="03">Question 34:</E>Would a tillerman, a person exercising control over the steerable rear axle(s) on a commercial motor vehicle (CMV), be considered a driver or “* * * person who operates a [CMV] * * *” (§ 383.3), and thus subject to applicable commercial driver's license regulations?</P>
            <P>
              <E T="03">Guidance:</E>
            </P>

            <P>A person physically located on the rear of the CMV who controls a steerable rear axle while the CMV is moving at<PRTPAGE P="32329"/>highway speeds would be considered a “* * * person who operates a commercial motor vehicle * * *” (§ 383.3), and would therefore be subject to the applicable commercial driver's license regulations in 49 CFR part 383.</P>
            <P>A person walking beside a CMV or riding in an escort car while controlling a steerable rear axle at slow speeds would not be considered a “* * * person who operates a [CMV] * * *” (§ 383.3), and therefore would not be subject to applicable commercial driver's license regulations.”</P>
          </PART>
        </REGTEXT>
        <REGTEXT PART="390" TITLE="49">
          <PART>
            <HD SOURCE="HED">PART 390—FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL</HD>
            <HD SOURCE="HD2">Section 390.5, “Definitions.”</HD>
            <P>“<E T="03">Question 14:</E>Would a tillerman, a person exercising control over the steerable rear axle(s) on a commercial motor vehicle (CMV), be considered a driver as defined in § 390.5, and thus subject to 49 CFR Parts 390 to 399?</P>
            <P>
              <E T="03">Guidance:</E>
            </P>
            <P>A person physically located on the rear of the CMV who controls a steerable rear axle while the CMV is moving at highway speeds would be considered a driver as defined in § 390.5 and therefore would be subject to the regulations in 49 CFR parts 390-399.</P>
            <P>A person walking beside a CMV or riding in an escort car while controlling a steerable rear axle at slow speeds would not be considered a driver as defined in § 390.5 and would therefore not be subject to 49 CFR Parts 390 to 399.”</P>
          </PART>
        </REGTEXT>
        <SIG>
          <DATED>Issued on: May 25, 2011.</DATED>
          <NAME>Anne S. Ferro,</NAME>
          <TITLE>Administrator.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13902 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE P</BILCOD>
    </RULE>
  </RULES>
  <VOL>76</VOL>
  <NO>108</NO>
  <DATE>Monday, June 6, 2011</DATE>
  <UNITNAME>Proposed Rules</UNITNAME>
  <PRORULES>
    <PRORULE>
      <PREAMB>
        <PRTPAGE P="32330"/>
        <AGENCY TYPE="F">DEPARTMENT OF DEFENSE</AGENCY>
        <DEPDOC>[Docket ID DOD-2011-OS-0036]</DEPDOC>
        <CFR>2 CFR Chapter XI</CFR>
        <CFR>5 CFR Chapter XXVI</CFR>
        <CFR>32 CFR Chapters I, V, VI, VII, XII, and Subtitle A</CFR>
        <CFR>33 CFR Chapter II</CFR>
        <CFR>36 CFR Chapter III</CFR>
        <CFR>40 CFR Chapter VII</CFR>
        <CFR>48 CFR Chapters 1, 2, 52, and 54</CFR>
        <SUBJECT>Reducing Regulatory Burden; Retrospective Review Under E.O. 13563</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Office of the Secretary, DoD.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Request for information.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>As part of its implementation of Executive Order 13563, “Improving Regulation and Regulatory Review,” issued by the President on January 18, 2011, the Department of Defense is seeking comments and information from interested parties to assist DoD in reviewing its existing regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed. The purpose of the Department's review is to make the agency's regulatory program more effective and less burdensome in achieving its regulatory objectives. The Department of Defense will continue to work with the public and the business community to determine how its regulations can increase efficiency, transparency, and provide accountability.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>Comments are requested by July 6, 2011.</P>
        </EFFDATE>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
          <P>
            <E T="03">Federal Rulemaking Portal: http://www.regulations.gov</E>. Follow the instructions for submitting comments.</P>
          <P>
            <E T="03">Mail:</E>Federal Docket Management System Office, 1160 Defense Pentagon, OSD Mailroom 3C843, Washington, DC 20301-1160.</P>
          <P>
            <E T="03">Instructions:</E>All submissions received must include the agency name and docket number for this<E T="04">Federal Register</E>document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at<E T="03">http://www.regulations.gov</E>as they are received without change, including any personal identifiers or contact information.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Robert Cushing, Jr., 703-696-5282.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>

        <P>Executive Order 13563 recognizes the importance of maintaining a consistent culture of retrospective review and analysis throughout the executive branch. Pursuant to the Executive Order, the Department of Defense (DoD) is developing a preliminary plan for the periodic review of its existing regulations and reporting obligations. DoD's plan is designed to create a defined method and schedule for identifying certain significant rules that are obsolete, unnecessary, unjustified, excessively burdensome, or counterproductive. Its review processes are intended to facilitate the identification of rules that warrant repeal or modification, or strengthening, complementing, or modernizing rules where necessary or appropriate. The preliminary plan, along with this request for information and previously received public comments, will be available on<E T="03">http://www.regulations.gov</E>for public comment in the docket DOD-2011-OS-0036.</P>

        <P>The Department of Defense is committed to the principles of retrospective analysis in order to improve the effectiveness of the implementation of its regulations, improve transparency in the regulatory process through public participation, and to provide transparent documentation of its analysis. Consistent with the Department's commitment to public participation in the rulemaking process, the Department is soliciting views from the public on how best to conduct its analysis of existing DoD rules and how best to identify those rules that might be modified, streamlined, expanded, or repealed. It is also seeking views from the public on specific rules or Department-imposed obligations that should be altered or eliminated. DoD regulations may be viewed by going to the eCFR at<E T="03">http://ecfr.gpoaccess.gov</E>and searching titles 2, 5, 32, 33, 36, 40, and/or 48.</P>

        <P>The Department notes that this request for information is issued solely for information and program-planning purposes. While responses to this request do not bind the Department of Defense to any further actions related to the response, all submissions will be made publically available on<E T="03">http://www.regulations.gov</E>.</P>
        <SIG>
          <DATED>Dated: May 27, 2011.</DATED>
          <NAME>Aaron Siegel,</NAME>
          <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13765 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 5001-06-P</BILCOD>
    </PRORULE>
    <PRORULE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
        <CFR>5 CFR Chapter XLV</CFR>
        <CFR>21 CFR Chapter I</CFR>
        <CFR>25 CFR Chapter V</CFR>
        <CFR>42 CFR Chapters I and V</CFR>
        <CFR>45 CFR Subtitle A and Chapters II, III, IV, X, and XIII</CFR>
        <SUBJECT>Reducing Regulatory Burden; Retrospective Review Under Executive Order 13563</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Department of Health and Human Services.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Request for information.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>In accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” the Department of Health and Human Services (HHS) seeks public comment from interested parties on its Preliminary Plan for Retrospective Review of Existing Regulations. The purpose of the Preliminary Plan is to identify a preliminary list of regulations that are appropriate candidates for review over the next two years and establish an ongoing process of retrospective review of existing regulations by which HHS can determine whether any should be modified, streamlined, expanded, or<PRTPAGE P="32331"/>repealed. HHS anticipates that such reviews will make its regulatory program more effective and flexible and reduce unnecessary burdens on the regulated communities.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>Submit electronic or written comments by June 30, 2011.</P>
        </EFFDATE>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>To facilitate the receipt and processing of comments, HHS encourages interested persons to submit their comments electronically to the HHS Open Government Portal at<E T="03">http://www.hhs.gov/open</E>, or by using the Federal eRulemaking portal<E T="03">http://www.regulations.gov</E>(following instructions for submission of comments). Follow the instructions for submitting comments. Persons submitting comments electronically are encouraged not to submit paper copies. Persons interested in submitting comments on paper should send or deliver their comments (preferably three copies) to: Department of Health and Human Services, Office of Documents and Regulations Management, 200 Independence Avenue, SW., Suite 639G, Washington, DC 20201.</P>

          <P>All comments will be available to the public, without charge, online at<E T="03">http://www.regulations.gov</E>and<E T="03">http://www.hhs.gov/open</E>.</P>
          <P>
            <E T="03">Instructions:</E>The HHS Preliminary Plan is available for review, download, and comment at<E T="03">http://www.hhs.gov/open</E>. You may also request a copy of the HHS Preliminary Plan, identified by Docket No. by writing to the address below. All comment submissions received must include the Agency name and Docket No. for this Notice: HHS-ES-2011-002.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Oliver Potts (202) 690-6392.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>On January 18, 2011, President Obama issued Executive Order 13563 to improve regulation and regulatory review by requiring Federal agencies to design cost effective, evidence-based regulations that are compatible with economic growth, job creation, and competitiveness, and which rely on the best, most innovative, and least burdensome tools to achieve regulatory ends. To meet that objective, the President directed each Executive Branch agency to consider how best to promote periodic retrospective review of existing significant rules to determine if they are outmoded, ineffective, insufficient, or excessively burdensome. The President required each agency to submit its preliminary plan to the Office of Management and Budget's Office of Information and Regulatory Affairs by May 18, 2011.</P>

        <P>HHS submitted its preliminary plan in compliance with the President's Executive Order and now seeks public comment. The plan is available for viewing, downloading, and comment at the following Web site—<E T="03">http://www.hhs.gov/open/The</E>comment period will close on June 30, after which HHS will finalize its preliminary plan. HHS notes that this request for comment is issued solely for information and program-planning purposes and does not obligate the agency to take any further action.</P>
        <SIG>
          <DATED>Dated: June 1, 2011.</DATED>
          <NAME>Barbara J. Holland,</NAME>
          <TITLE>Deputy Executive Secretary to the Department.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13908 Filed 6-1-11; 4:15 pm]</FRDOC>
      <BILCOD>BILLING CODE 4150-24-P</BILCOD>
    </PRORULE>
    <PRORULE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <CFR>6 CFR Chapter I</CFR>
        <CFR>8 CFR Chapter I</CFR>
        <CFR>19 CFR Chapter I</CFR>
        <CFR>33 CFR Chapter I</CFR>
        <CFR>44 CFR Chapter I</CFR>
        <CFR>46 CFR Chapters I and III</CFR>
        <CFR>49 CFR Chapter XII</CFR>
        <DEPDOC>[Docket No. DHS-2011-0015]</DEPDOC>
        <SUBJECT>Preliminary Plan for Retrospective Review of Existing Regulations</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Office of the General Counsel, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of availability; request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of Homeland Security (DHS) announces the availability of its Preliminary Plan for Retrospective Review of Existing Regulations (Preliminary Plan). Pursuant to Executive Order 13563, “Improving Regulation and Regulatory Review,” which the President issued on January 18, 2011, DHS developed its Preliminary Plan to facilitate the review of existing DHS regulations through the use of retrospective review. DHS is seeking public comment on its Preliminary Plan.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments are requested on or before June 25, 2011. Late-filed comments will be considered to the extent practicable.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>You may submit comments, identified by docket number DHS-2011-0015, through the<E T="03">Federal eRulemaking Portal:</E>
            <E T="03">http://www.regulations.gov.</E>Follow the instructions for submitting comments.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Christina E. McDonald, Acting Associate General Counsel for Regulatory Affairs, U.S. Department of Homeland Security, Office of the General Counsel. E-mail:<E T="03">Regulatory.Review@dhs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">I. Public Participation</HD>

        <P>Interested persons are invited to comment on this notice by submitting written data, views, or arguments using the method identified in the<E T="02">ADDRESSES</E>section.</P>
        <P>
          <E T="03">Instructions:</E>All submissions must include the agency name and docket number for this notice. All comments received will be posted without change to<E T="03">http://www.regulations.gov.</E>
        </P>
        <P>
          <E T="03">Docket:</E>For access to the docket to read background documents or comments received, go to<E T="03">http://www.regulations.gov</E>.</P>
        <HD SOURCE="HD1">II. Background</HD>
        <P>On January 18, 2011, the President issued Executive Order 13563, “Improving Regulation and Regulatory Review,” to ensure that Federal regulations seek more affordable, less intrusive means to achieve policy goals and that agencies give careful consideration to the benefits and costs of those regulations. 76 FR 3821. The Executive Order requires each Executive Branch agency to develop a preliminary plan to periodically review its existing regulations to determine whether any regulations should be modified, streamlined, expanded, or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving its regulatory objectives.</P>

        <P>DHS's approach to conducting retrospective review focuses on public openness and transparency and on the critical role of public input in conducting retrospective review. To that end, DHS published a notice and request for comments in the<E T="04">Federal Register</E>on March 14, 2011, “Reducing Regulatory Burden; Retrospective Review Under Executive Order 13563.” 76 FR 13526. In that notice, DHS solicited public input on how DHS should structure its retrospective review and which DHS rules would benefit from retrospective review. In addition, DHS launched an IdeaScale Web page; this social media tool provided an additional means for DHS to solicit input from the public, and more<PRTPAGE P="32332"/>importantly, to foster dialogue among members of the public.</P>

        <P>DHS has incorporated the public input in developing its Preliminary Plan. The Preliminary Plan establishes a process for identifying regulations that may be obsolete, unnecessary, unjustified, excessively burdensome, or counterproductive. The DHS retrospective review process will help identify rules that warrant repeal or modification, or strengthening, complementing, or modernizing, where necessary or appropriate. The DHS Preliminary Plan is available for viewing online at<E T="03">http://www.dhs.gov/xabout/open-government.shtm</E>and<E T="03">http://www.regulations.gov</E>.  We welcome public comment on its content.</P>
        <SIG>
          <NAME>Ivan K. Fong,</NAME>
          <TITLE>General Counsel.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13801 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9110-9B-P</BILCOD>
    </PRORULE>
    <PRORULE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Office of the Comptroller of the Currency</SUBAGY>
        <CFR>12 CFR Parts 4, 5, 7, 8, 28, and 34</CFR>
        <DEPDOC>[Docket ID OCC-2011-0006]</DEPDOC>
        <RIN>RIN 1557-AD41</RIN>
        <SUBJECT>Office of Thrift Supervision Integration; Dodd-Frank Act Implementation; Correction</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Office of the Comptroller of the Currency, Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of proposed rulemaking; correction.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>The Office of the Comptroller of the Currency (OCC) published in the<E T="04">Federal Register</E>on May 26, 2011, a notice of proposed rulemaking entitled “Office of Thrift Supervision Integration; Dodd-Frank Act Implementation.” Inadvertently, an incorrect E-mail address was used in the<E T="02">ADDRESSES</E>caption for submission of public comments directly to the OCC via electronic mail. This document corrects that E-mail address.</P>
        </SUM>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Andra Shuster, Special Counsel, Heidi Thomas, Special Counsel, or Stuart Feldstein, Director, Legislative and Regulatory Activities Division, (202) 874-5090; Timothy Ward, Deputy Comptroller for Thrift Supervision, (202) 874-4468; or Frank Vance, Manager, Disclosure Services and Administrative Operations, Communications Division, (202)-874-5378, Office of the Comptroller of the Currency, 250 E Street, SW., Washington, DC 20219.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The OCC published a document in the<E T="04">Federal Register</E>on May 26, 2011 (76 FR 30557) requesting comment on its notice of proposed rulemaking entitled “Office of Thrift Supervision Integration; Dodd-Frank Act Implementation.” The e-mail address for submission of comments was incorrectly included as “<E T="03">regs.comments@occ.treas.gov</E>”. The correct address is “<E T="03">regs.comments@occ.treas.gov</E>”.</P>

        <P>In FR Doc. 2011-12859, published on May 26, 2011 (76 FR 30557), make the following correction. On page 30557, in the second column, remove “E-mail:<E T="03">regs.comments@occ.gov</E>” and replace it with “E-mail:<E T="03">regs.comments@occ.treas.gov</E>”.</P>
        <SIG>
          <DATED>Dated: June 1, 2011.</DATED>
          <NAME>Julie L. Williams,</NAME>
          <TITLE>First Senior Deputy Comptroller and Chief Counsel.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13887 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4810-33-P</BILCOD>
    </PRORULE>
    <PRORULE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
        <SUBAGY>Food and Drug Administration</SUBAGY>
        <CFR>21 CFR Part 573</CFR>
        <DEPDOC>[Docket No. FDA-2011-F-0365]</DEPDOC>
        <SUBJECT>BASF Corp.; Filing of Food Additive Petition (Animal Use); Methyl Esters of Conjugated Linoleic Acid; Silicon Dioxide</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Food and Drug Administration, HHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of petition.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of methyl esters of conjugated linoleic acid (CLA) as a source of fatty acids in lactating dairy cow diets and for use of silicon dioxide as a carrier for the methyl esters of CLA.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>Submit either electronic or written comments on the petitioner's environmental assessment by July 6, 2011.</P>
        </EFFDATE>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit electronic comments to<E T="03">http://www.regulations.gov.</E>Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Isabel W. Pocurull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6853,<E T="03">isabel.pocurull@fda.hhs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>

        <P>Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 2269) has been filed by BASF Corp. (BASF), 100 Campus Dr., Florham Park, NJ 07932. The petition proposes to amend the food additive regulations in part 573<E T="03">Food Additives Permitted in Feed and Drinking Water of Animals</E>(21 CFR part 573) to provide for the safe use of methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) as a source of fatty acids in lactating dairy cow diets. BASF's FAP 2269 further proposes the use of silicon dioxide as a carrier for methyl esters of CLA.</P>

        <P>The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the Agency is placing the environmental assessment submitted with the petition that is the subject of this notice on public display at the Division of Dockets Management (see<E T="02">DATES</E>and<E T="02">ADDRESSES</E>) for public review and comment.</P>

        <P>Interested persons may submit to the Division of Dockets Management (see<E T="02">ADDRESSES</E>) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place on public display any amendments to, or comments on, the petitioner's environmental assessment without further announcement in the<E T="04">Federal Register</E>. If, based on its review, the Agency finds that an environmental impact statement is not required, and this petition results in a regulation, the notice of availability of the Agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the<E T="04">Federal Register</E>in accordance with 21 CFR 25.51(b).</P>
        <SIG>
          <PRTPAGE P="32333"/>
          <DATED>Dated: May 31, 2011.</DATED>
          <NAME>Bernadette Dunham,</NAME>
          <TITLE>Director, Center for Veterinary Medicine.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13907 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4160-01-P</BILCOD>
    </PRORULE>
    <PRORULE>
      <PREAMB>
        <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
        <CFR>40 CFR Part 52</CFR>
        <DEPDOC>[EPA-R03-OAR-2011-0379; FRL-9314-5]</DEPDOC>
        <SUBJECT>Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Revision to the Inspection and Maintenance (I/M) Program—Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Environmental Protection Agency (EPA).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Proposed rule.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania for the purpose of changing the quality assurance program for its motor vehicle inspection and maintenance program (I/M program). Specifically, the Commonwealth is amending a provision of its prior SIP-approved I/M program to amend the duration of the timing of quality assurance audits performed by the Pennsylvania Department of Transportation (PENNDOT) as part of their program oversight. The amendment allows for these audits to be conducted within five days of vehicle inspection, instead of the two day window allowed under the prior approved SIP. In the Final Rules section of this<E T="04">Federal Register</E>, EPA is approving the Commonwealth's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>Comments must be received in writing by July 6, 2011.</P>
        </EFFDATE>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit your comments, identified by Docket ID Number EPA-R03-OAR-2011-0379 by one of the following methods:</P>
          <P>A.<E T="03">http://www.regulations.gov.</E>Follow the on-line instructions for submitting comments.</P>
          <P>B.<E T="03">E-mail: fernandez.cristina@epa.gov.</E>
          </P>
          <P>C.<E T="03">Mail:</E>EPA-R03-OAR-2011-0379, Cristina Fernandez, Associate Director, Office of Air Program Planning, Mailcode 3AP30, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.</P>
          <P>D.<E T="03">Hand Delivery:</E>At the previously-listed EPA Region III address. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.</P>
          <P>
            <E T="03">Instructions:</E>Direct your comments to Docket ID No. EPA-R03-OAR-2011-0379. EPA's policy is that all comments received will be included in the public docket without change, and may be made available online at<E T="03">http://www.regulations.gov,</E>including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through<E T="03">http://www.regulations.gov</E>or e-mail. The<E T="03">http://www.regulations.gov</E>Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through<E T="03">http://www.regulations.gov,</E>your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.</P>
          <P>
            <E T="03">Docket:</E>All documents in the electronic docket are listed in the<E T="03">http://www.regulations.gov</E>index. Although listed in the index, some information is not publicly available,<E T="03">i.e.,</E>CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in<E T="03">http://www.regulations.gov</E>or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Pennsylvania Department of Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market Street, Harrisburg, Pennsylvania 17105.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Brian Rehn, (215) 814-2176, or by e-mail at<E T="03">rehn.brian@epa.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>

        <P>For further information, please see the information provided in the direct final action, with the same title, that is located in the Rules and Regulations section of this<E T="04">Federal Register</E>publication.</P>
        <SIG>
          <DATED>Dated: May 18, 2011.</DATED>
          <NAME>Shawn M. Garvin,</NAME>
          <TITLE>Regional Administrator, Region III.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13879 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6560-50-P</BILCOD>
    </PRORULE>
    <PRORULE>
      <PREAMB>
        <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
        <CFR>40 CFR Part 52</CFR>
        <DEPDOC>[EPA-R06-OAR-2010-0978; FRL-9315-3]</DEPDOC>
        <SUBJECT>Approval and Promulgation of Implementation Plans; Texas; Revisions to the New Source Review (NSR) State Implementation Plan (SIP); Permit Renewals</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Environmental Protection Agency (EPA).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Proposed rule.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>EPA is proposing to approve revisions to the applicable State Implementation Plan (SIP) for the State of Texas that relate to the Permit Renewals. These portions of the SIP revisions proposed for approval address the following requirements related to Permit Renewals: Notification of permit holder, permit renewal application, and review schedule. EPA finds that these changes to the Texas SIP comply with the Federal Clean Air Act (the Act or CAA) and EPA regulations and are consistent with EPA policies. EPA is proposing this action under section 110 of the Act.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Comments must be received on or before July 6, 2011.</P>
        </DATES>
        <ADD>
          <PRTPAGE P="32334"/>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit your comments, identified by Docket ID No. EPA-R06-OAR-2010-0978 by one of the following methods:</P>
          <P>(1)<E T="03">Federal eRulemaking Portal:</E>
            <E T="03">http://www.regulations.gov.</E>Follow the on-line instructions for submitting comments.</P>
          <P>(2)<E T="03">E-mail:</E>Mr. Stanley M. Spruiell at<E T="03">spruiell.stanley@epa.gov.</E>
          </P>
          <P>(3)<E T="03">U.S. EPA Region 6 “Contact Us” Web site: http://epa.gov/region6/r6coment.htm.</E>Please click on “6PD” (Multimedia) and select “Air” before submitting comments.</P>
          <P>(4)<E T="03">Fax:</E>Mr. Stanley M. Spruiell, Air Permits Section (6PD-R), at fax number 214-665-6762.</P>
          <P>(5)<E T="03">Mail:</E>Mr. Stanley M. Spruiell, Air Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733.</P>
          <P>(6)<E T="03">Hand or Courier Delivery:</E>Mr. Stanley M. Spruiell, Air Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are accepted only between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal holidays. Special arrangements should be made for deliveries of boxed information.</P>
          <P>
            <E T="03">Instructions:</E>Direct your comments to Docket ID No. EPA-R06-OAR-2010-0978. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at<E T="03">http//www.regulations.gov,</E>including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through<E T="03">http://www.regulations.gov</E>or e-mail. The<E T="03">http://www.regulations.gov</E>Web site is an “anonymous access” system, which means that EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through<E T="03">http://www.regulations.gov</E>your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.</P>
          <P>
            <E T="03">Docket:</E>All documents in the docket are listed in the<E T="03">http://www.regulations.gov</E>index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in<E T="03">http://www.regulations.gov</E>or in hard copy at the Air Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. The file will be made available by appointment for public inspection in the Region 6 Freedom of Information Act Review Room between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal holidays. Contact the person listed in the<E T="02">FOR FURTHER INFORMATION CONTACT</E>paragraph below or Mr. Bill Deese at (214) 665-7253 to make an appointment. If possible, please make the appointment at least two working days in advance of your visit. There will be a 15 cent per page fee for making photocopies of documents. On the day of the visit, please check in at the EPA Region 6 reception area at 1445 Ross Avenue, Suite 700, Dallas, Texas.</P>
          <P>The State submittals, which are part of the EPA docket, are also available for public inspection at the State Air Agency during official business hours by appointment: Texas Commission on Environmental Quality (TCEQ), Office of Air Quality, 12124 Park 35 Circle, Austin, Texas 78753.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Mr. Stanley M. Spruiell, Air Permits Section (6PD-R), Environmental Protection Agency, Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733, telephone (214) 665-7212; fax number (214) 665-6762; e-mail address<E T="03">spruiell.stanley@epa.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>Throughout this document wherever any reference to “we,” “us,” or “our” is used, we mean EPA.</P>
        <HD SOURCE="HD1">Table of Contents</HD>
        <EXTRACT>
          <FP SOURCE="FP-2">I. The State's Submittals</FP>
          <FP SOURCE="FP1-2">A. What is the background of the Texas permit renewal program?</FP>
          <FP SOURCE="FP1-2">B. What changes did the State submit?</FP>
          <FP SOURCE="FP-2">II. What action is EPA proposing to take?</FP>
          <FP SOURCE="FP-2">III. EPA's Evaluation</FP>
          <FP SOURCE="FP1-2">A. Section 30 TAC 116.310—Notification of Permit Holder</FP>
          <FP SOURCE="FP1-2">1. What is the background of 30 TAC 116.310?</FP>
          <FP SOURCE="FP1-2">2. What did Texas submit for 30 TAC 116.310?</FP>
          <FP SOURCE="FP1-2">3. What is EPA's evaluation of the submitted revisions to 30 TAC 116.310?</FP>
          <FP SOURCE="FP1-2">B. Section 30 TAC 116.311—Permit Renewal Application</FP>
          <FP SOURCE="FP1-2">1. What is the background of 30 TAC 116.311?</FP>
          <FP SOURCE="FP1-2">2. What did Texas submit for 30 TAC 116.311?</FP>
          <FP SOURCE="FP1-2">3. What is EPA's evaluation of the submitted revisions to 30 TAC 116.311?</FP>
          <FP SOURCE="FP1-2">C. Section 30 TAC 116.314—Review Schedule</FP>
          <FP SOURCE="FP1-2">1. What is the background of 30 TAC 116.314?</FP>
          <FP SOURCE="FP1-2">2. What did Texas submit for 30 TAC 116.314?</FP>
          <FP SOURCE="FP1-2">3. What is EPA's evaluation of the submitted revisions to 30 TAC 116.314?</FP>
          <FP SOURCE="FP-2">IV. Proposed Action</FP>
          <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP>
        </EXTRACT>
        <HD SOURCE="HD1">I. The State's Submittals</HD>
        <HD SOURCE="HD2">A. What is the background of the Texas permit renewal program?</HD>
        <P>In this action, EPA is proposing to approve revisions to the Texas regulations relating to renewal of preconstruction permits. The rules for permit renewals are currently approved in the Texas SIP under 30 TAC 116.310, 116.311, 116.312, 116.313, 116.314, and 116.315. EPA approved these rules on March 10, 2006 (71 FR 12285), and revisions on March 20, 2009 (74 FR 11851), and March 11, 2010 (75 FR 11464). The approved rules require each preconstruction permit to be renewed every ten years. Permit renewal is approved based upon a demonstration in the renewal application that the permitted facility will operate in accordance with all requirements and conditions of the existing permit, including representations in the application to construct, and subsequent amendments, any previously granted renewal, and the compliance history of the facility. Although preconstruction permits must remain in effect as long as the source operates and until voided under the approved implementation procedures, periodic renewal of preconstruction permits is neither required nor prohibited under the Act or Federal Regulations.</P>
        <HD SOURCE="HD2">B. What changes did the State submit?</HD>

        <P>On December 15, 1995; July 22, 1998; and September 4, 2002; the State of Texas submitted revisions to the Texas State Implementation Plan (SIP) concerning the Permit Renewals under Title 30 of the Texas Administrative Code (30 TAC), Chapter 116—Control of Air Pollution by Permits for New Construction or Modification, Subchapter D—Permit Renewals. The<PRTPAGE P="32335"/>December 15, 1995, revisions to these provisions were superseded and rendered moot by revisions submitted to EPA on July 22, 1998, because the latter submittal repealed and replaced the earlier versions of the same provisions addressed in the December 15, 1995, submittal. Submitted revisions included changes to 30 TAC 116.310—Notification of Permit Holder, 30 TAC 116.311—Permit Renewal Application, 30 TAC 116.312—Public Notification and Comment Procedures, 30 TAC 116.313—Renewal Application Fees, 30 TAC 116.314—Review Schedule, and 30 TAC 116.315—Permit Renewal Submittal. In this proposed action, we are addressing submitted revisions to 30 TAC 116.310, 116.311, and 116.314.</P>
        <P>Section 30 TAC 116.310—Notification of Permit Holder—is currently approved as adopted by Texas on August 16, 1993, approved March 10, 2006 (71 FR 12285). Today, we propose to approve revisions adopted by Texas on November 16, 1995 (submitted December 15, 1995) and June 17, 1998 (submitted July 22, 1998).</P>
        <P>Section 30 TAC 116.311—Permit Renewal Application—is currently approved as adopted by Texas on April 6, 1994, approved March 10, 2006 (71 FR 12285). The requirements of subsection (c) were later removed from 30 TAC 116.311 and added to Section 116.315 and approved by EPA on March 11, 2010, 75 FR 11464. Today, we propose to approve other revisions adopted by Texas on November 16, 1995 (submitted December 15, 1995); June 17, 1998 (submitted July 22, 1998); and August 21, 2002 (submitted September 4, 2002). Today's proposed action does not address severable revisions to 30 TAC 116.311(a)(2) submitted December 15, 1995; July 22, 1998; and September 4, 2002. This provision was revised to exclude changes under the severable provisions relating to Qualified Facilities. EPA will review these revisions to 30 TAC 116.311(a)(2) in connection with separately submitted revisions to Texas Qualified Facilities Program, submitted October 5, 2010.</P>
        <P>Section 30 TAC 116.314—Review Schedule—is currently approved as adopted by Texas on August 16, 1993, approved March 10, 2006 (71 FR 12285). Today, we propose to approve revisions adopted by Texas on November 16, 1995 (submitted December 15, 1995) and June 17, 1998 (submitted July 22, 1998).</P>
        <P>Additional information related to these SIP submittals is contained in the Technical Support Document (TSD), which is in the docket for this action.</P>
        <P>The table below summarizes the changes that were submitted and are affected by this action. A summary of EPA's evaluation of each section and the basis for this proposal is discussed in section III of this preamble. The TSD includes a detailed evaluation of the referenced SIP submittals.</P>
        <GPOTABLE CDEF="s50,r50,14,14,r100" COLS="5" OPTS="L2,tp0,i1">
          <TTITLE/>
          <BOXHD>
            <CHED H="1">Section</CHED>
            <CHED H="1">Title</CHED>
            <CHED H="1">Date submitted</CHED>
            <CHED H="1">Date adopted by the State</CHED>
            <CHED H="1">Comments</CHED>
          </BOXHD>
          <ROW RUL="s">
            <ENT I="01">30 TAC 116.310</ENT>
            <ENT>Notification of Permit Holder</ENT>
            <ENT>*12/15/1995<LI>*7/22/1998</LI>
            </ENT>
            <ENT>*11/16/1995<LI>*6/17/1998</LI>
            </ENT>
            <ENT>—Non-substantive changes to the section.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">30 TAC 116.311</ENT>
            <ENT>Permit Renewal Application</ENT>
            <ENT>*12/15/1995<LI>*7/22/1998</LI>
            </ENT>
            <ENT>*11/16/1995<LI>*6/17/1998</LI>
            </ENT>
            <ENT>—Removed paragraphs (a)(1), (a)(3), and (a)(4) and redesignated existing paragraphs (a)(2), (a)(5), and (a)(6) to paragraphs (a)(1)-(a)(3), respectively.</ENT>
          </ROW>
          <ROW>
            <ENT I="22"/>
            <ENT O="xl"/>
            <ENT/>
            <ENT/>
            <ENT>—Added new paragraphs (a)(4) and (a)(5).</ENT>
          </ROW>
          <ROW>
            <ENT I="22"/>
            <ENT O="xl"/>
            <ENT/>
            <ENT/>
            <ENT>—Added new subsection (b).<LI>—Revised and redesignated existing subsection (b) to new subsection (c).</LI>
            </ENT>
          </ROW>
          <ROW RUL="s">
            <ENT I="22"/>
            <ENT O="xl"/>
            <ENT>9/4/2002</ENT>
            <ENT>8/21/2002</ENT>
            <ENT>—Added new paragraph (a)(1) and redesignated existing paragraphs (a)(1)-(a)(5) to paragraphs (a)(2)-(a)(6), respectively.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">30 TAC 116.314</ENT>
            <ENT>Review Schedule</ENT>
            <ENT>*12/15/1995<LI>*7/22/1998</LI>
            </ENT>
            <ENT>*11/16/1995<LI>*6/17/1998</LI>
            </ENT>
            <ENT>—Revised and reorganized subsection (a) into subsections (a) and (b) and revisions to these subsections.</ENT>
          </ROW>
          <ROW>
            <ENT I="22"/>
            <ENT O="xl"/>
            <ENT/>
            <ENT/>
            <ENT>—Revised and redesignated existing subsections (b) and (c) to subsections (c) and (d), respectively.</ENT>
          </ROW>
          <TNOTE>* Because Texas repealed and resubmitted each section under Subchapter D in its 7/22/1998 submittal, our analysis includes 12/15/95 and 7/22/98 SIP submittal together.</TNOTE>
        </GPOTABLE>
        <HD SOURCE="HD1">II. What action is EPA proposing to take?</HD>
        <P>We have evaluated the SIP submissions for consistency with the CAA, NSR regulations for new and modified sources in 40 CFR Part 51, and the approved Texas SIP. We have also reviewed the rules for enforceability and legal sufficiency. On March 10, 2006, EPA approved revisions to 30 TAC, Chapter 116—Control of Air Pollution by Permits for New Construction or Modification, Subchapter D—Permit Renewals, Sections 116.310, 116.311, 116.312, 116.313, and 116.314. On March 11, 2010 (75 FR 11464), EPA approved the removal of subsection (c) from 30 TAC 116.311 and added those provisions to 30 TAC 116.315. Section 30 TAC 116.312 relates to public participation and is severable from the remaining rules (see 75 FR 68291, 68294). We will address the requirements for public participation in a separate action when we act on the Texas rules relating to public participation, submitted July 12, 2010. Under the CAA, EPA's statutory deadline to act on the revised public participation rules is January 12, 2012. The revisions to 30 TAC 116.313 were approved in a separate action on March 20, 2009 (74 FR 11851). The revisions to 116.315 were approved in a separate action on March 11, 2010 (75 FR 11464).</P>

        <P>This proposed action addresses revisions to 30 TAC 116.310, 116.311, and 116.314, submitted December 15, 1995, and July 22, 1998, and revisions to 30 TAC 116.311 submitted September 4, 2002. A technical analysis of the submittals for the Permit Renewal Application and Permit Renewal Submittal sections has found that these changes are consistent with the CAA, 40 CFR Part 51 and EPA policies. Therefore, EPA proposes to approve the<PRTPAGE P="32336"/>revisions to 30 TAC 116.310, 116 .311,<SU>1</SU>
          <FTREF/>and 116.314 submitted on December 15, 1995; July 22, 1998; and September 4, 2002.</P>
        <FTNT>
          <P>
            <SU>1</SU>Except for 30 TAC 116.311(a)(2). See discussion in section III.B of this preamble for further information on these provisions.</P>
        </FTNT>
        <HD SOURCE="HD1">III. EPA's Evaluation</HD>
        <HD SOURCE="HD2">A. Section 30 TAC 116.310—Notification of Permit Holder</HD>
        <HD SOURCE="HD3">1. What is the background of 30 TAC 116.310?</HD>
        <P>The currently approved provisions for 30 TAC 116.310 were submitted to EPA on August 31, 1993. EPA approved the submitted revisions on March 10, 2006 (71 FR 12285). These revisions became effective on May 9, 2006.</P>
        <HD SOURCE="HD3">2. What did Texas submit for 30 TAC 116.310?</HD>
        <P>Since EPA's last approval for this section, TCEQ has submitted two SIP revisions to EPA for the Notification of Permit Holder in 30 TAC 116.310 on December 15, 1995, and July 22, 1998. In this proposed action, we are proposing to approve the revisions of the existing provisions of section 116.310. The revisions submitted to this section include updated references to the current agency name and update of a state statutory citation to the current citation.</P>
        <HD SOURCE="HD3">3. What is EPA's evaluation of the submitted revisions to 30 TAC 116.310?</HD>
        <P>These submitted revisions are non-substantive and do not change the underlying requirements of the section as currently approved. We propose to approve the revisions to 30 TAC 116.310 as submitted December 15, 1995, and July 22, 1998.</P>
        <HD SOURCE="HD2">B. Section 30 TAC 116.311—Permit Renewal Application</HD>
        <HD SOURCE="HD3">1. What is the background of 30 TAC 116.311?</HD>
        <P>The currently approved provisions for 30 TAC 116.311 were submitted to EPA on August 31, 1993, and April 29, 1994. EPA approved the submitted revisions on March 10, 2006 (71 FR 12285). These revisions became effective on May 9, 2006.</P>
        <HD SOURCE="HD3">2. What did Texas submit for 30 TAC 116.311?</HD>
        <P>Since EPA's last approval for this section, TCEQ has submitted three SIP revisions to EPA for the Permit Renewal Application section on December 15, 1995; July 22, 1998; and September 4, 2002. On March 11, 2010, we approved the recodification and revision of the existing provisions of section 116.311(c) to a new section 116.315—Permit Renewal Submittal. In this proposed action, we are addressing the remaining revisions as described below, except for the revisions to 30 TAC 116.311(a)(2) and (a)(6). This includes the following revisions:</P>
        <P>a. Revisions submitted December 15, 1995, and July 22, 1998.</P>
        <P>These revisions include:</P>
        <P>• Removal of paragraphs (a)(1), (a)(3), and (a)(4), and the redesignation of existing paragraphs (a)(2), (a)(5), and (a)(6) to paragraphs (a)(1) through (a)(3), respectively;</P>
        <P>• Addition of new paragraphs (a)(4) and (a)(5);</P>
        <P>• Addition of new subsection (b); and</P>
        <P>• Redesignation of existing subsection (b) to subsection (c) with non-substantive revisions.</P>
        <P>b. Revisions submitted September 4, 2002.</P>
        <P>These revisions include the addition of new paragraph (a)(1) and redesignation of existing paragraphs (a)(1) through (a)(5) to paragraphs (a)(2) through (a)(6), respectively.</P>
        <P>3. What is EPA's evaluation of the submitted revisions to 30 TAC 116.311?</P>
        <P>a. The addition of new paragraph (a)(1).</P>
        <P>Texas submitted paragraph (a)(1) on September 4, 2002. This paragraph ensures that upon renewal, “dockside vessel emissions associated with the permitted facility will comply with all rules and regulations of the commission and with the intent of the TCAA, including protection of the health and property of the public and minimization of emissions to the extent possible, consistent with good air pollution practices.” This revision is consistent with the provision in the SIP-approved 30 TAC 116.111(a)(2) as it relates to associated dockside vessel emissions. See 72 FR 49198 (August 28, 2007). The TCEQ obtained the authority to regulate dockside emissions under House Bill (HB) 3040, 77th Legislature, 2001 which amended the Texas Health and Safety Code (THSC), Texas Clean Air Act (TCAA), § 382.065 (Acts 2001, 77th Legislature, Chapter 1166, § 1). See page 2 of the TCEQ's evaluation of the revisions submitted September 4, 2002. The TCEQ further states:</P>
        
        <EXTRACT>
          <P>The commission determined that dockside vessels are facilities as defined in TCAA, § 382.003(6), and thus subject to the requirements of Chapter 116. These emissions will require best available control technology (BACT) review, maximum allowable emission limitations, monitoring, testing, recordkeeping, and ambient air impacts review. The emissions originating from a dockside vessel that are the result of functions performed by onshore facilities or using onshore equipment include: Loading and unloading of liquid bulk materials, liquified gaseous materials, and solid bulk materials; cleaning and degassing liquid vessel compartments; and abrasive blasting and painting.</P>
        </EXTRACT>
        
        <FP>See page 4 of the TCEQ's evaluation of the revisions submitted September 4, 2002. Finally, concerning the revision to 30 TAC 116.311, the TCEQ states:</FP>
        
        <EXTRACT>
          <P>The adopted amendment to § 116.311, Permit Renewal Application, requires that owners or operators submit information that demonstrates that dockside emissions comply with all commission rules and regulations and the intent of the TCAA, including protection of the health and property of the public and the minimization of emissions to the extent practicable, consistent with good air pollution control practices. Existing dockside emissions will be reviewed for off-property effects considering magnitude, frequency, and duration.</P>
        </EXTRACT>
        
        <FP>See page 4 of the TCEQ's evaluation of the revisions submitted September 4, 2002. The addition of new paragraph (a)(1) ensures that permits to construct and permit renewals that pre-date TCEQ's rule change to regulate dockside emissions at 30 TAC 116.111(a)(2) are required at renewal to ensure all dockside emissions comply with the statute and regulations. We propose to approve the addition of paragraph (a)(1), submitted September 4, 2002.</FP>
        <P>b. The removal of existing paragraph (a)(1).</P>
        <P>This paragraph provides that upon renewal the emissions from the facility will comply with all applicable specifications and requirements in the Texas Air Control Board (TACB)<SU>2</SU>

          <FTREF/>rules and the Texas Clean Air Act (TCAA). Texas submitted the removal of existing paragraph (a)(1) on December 15, 1995, and July 22, 1998. EPA believes this provision is redundant because the SIP already contains the substantive requirement at 30 TAC 116.115(b)(2)(H)(ii) requiring that “[i]f more than one state or Federal regulation or permit condition are applicable, the most stringent limit or condition shall govern and be the standard by which compliance shall be demonstrated.” The SIP also provides TCEQ with the authority to re-evaluate a source's ability to comply with the statute and regulations at renewal, as provided in the existing SIP rule at 30 TAC 116.311(b), which is recodified to 30 TAC 116.311(c) in this proposal. Because the proposed removal of this paragraph merely is the removal of a redundant requirement, it is not a relaxation of the SIP. Therefore,<PRTPAGE P="32337"/>approval of this revision will not interfere with attainment and reasonable further progress or any other applicable Federal requirement, as required by section 110(l) of the CAA. Accordingly, we propose to approve the removal of existing paragraph (a)(1), submitted December 15, 1995, and July 22, 1998.</P>
        <FTNT>
          <P>
            <SU>2</SU>The TACB is a predecessor agency to the TCEQ.</P>
        </FTNT>
        <P>c. Revisions to paragraph (a)(2).</P>
        <P>As currently approved, paragraph (a)(2) provides that upon renewal, facility is being operated in accordance with all requirements and conditions of the existing permit, including representations in the application for permit to construct and subsequent amendments, and any previously granted renewal. This paragraph was revised and redesignated to paragraph (a)(1) in the December 15, 1995, and July 22, 1998, SIP submittals. This paragraph was again redesignated to paragraph (a)(2) in the September 4, 2002, SIP submittal. The revisions submitted December 15, 1995, and July 22, 1998, as redesignated in the September 4, 2002, SIP submittal, were revised to add a provision that excludes changes otherwise authorized for a Qualified Facility. The submitted revisions to paragraph (a)(2) are related to severable provisions that relate to Qualified Facilities that we disapproved on April 14, 2010 (75 FR 19467) and to the separately submitted revisions to the Qualified Facilities Program on October 5, 2010. We propose to take no action on the severable submitted revision to paragraph (a)(2) relating to Qualified Facilities, and we will address these revisions in a separate action on the submitted revisions to the Qualified Facilities Program. The approved SIP will retain currently approved paragraph (a)(2) as adopted by Texas on April 4, 1994 (submitted April 29, 1994), and approved March 10, 2006.</P>
        <P>d. The removal of existing paragraph (a)(3).</P>
        <P>This paragraph required that upon renewal the facility will continue to have appropriate means to measure the emission of significant air contaminants as determined necessary by the Executive Director. Texas submitted the removal of paragraph (a)(3) on December 15, 1995, and July 22, 1998. In its December 15, 1995 submittal, Texas stated:</P>
        
        <EXTRACT>
          <P>Existing § 116.311(a)(3) also duplicates a requirement applicable to the original permit application. An applicant for a permit to construct must demonstrate that a facility will have provisions for measuring the emissions of significant air contaminants, including the installation of sampling ports and sampling platforms. When necessary, such requirements are written as conditions of the permit. The renewal review will determine whether a facility is in compliance with any sampling requirements in its permit. * * *  [A]n owner/operator could not remove sampling ports or platforms in violation of permit conditions.</P>
          <P>Further, 30 TAC § 101.9 provides independent authority for the TNRCC to require sampling ports and platforms when necessary. The existing § 116.311(a)(3) was redundant and unnecessary.</P>
        </EXTRACT>
        
        <FP>See the December 15, 1995 SIP submittal at page 5 of the Section entitled “Evaluation of Testimony.” EPA believes this provision is redundant because the SIP already contains the substantive requirement in the rules at 30 TAC 101.9 and 30 TAC 116.111(a)(2)(B). These two SIP rules require the following:</FP>
        
        <EXTRACT>
          <P>Any person, at the request of the Texas Natural Resource Conservation Commission (TNRCC or Commission), shall provide in connection with each flue a power source near the point of testing in addition to such sampling and testing facilities and sampling ports, including safe and easy access thereto, exclusive of instruments and sensing devices, as may be necessary for the Commission to determine the nature and quality of emissions which are or may be discharged as a result of source operations. Evidence and data based on these samples and calculations may be used to substantiate violations of the Act, rules, and regulations. Agents of the Commission shall be permitted to sample the stacks during operating hours.</P>
        </EXTRACT>
        
        <FP>30 TAC 101.9</FP>
        
        <EXTRACT>
          <P>(B) Measurement of emissions. The proposed facility will have provisions for measuring the emission of significant air contaminants as determined by the executive director. This may include the installation of sampling ports on exhaust stacks and construction of sampling platforms in accordance with guidelines in the “Texas Natural Resource Conservation Commission (TNRCC) Sampling Procedures Manual.”</P>
        </EXTRACT>
        
        <FP>30 TAC 116.111(a)(2)(B). Because the proposed removal of this paragraph merely is the removal of a redundant requirement, it is not a relaxation of the SIP. Therefore, approval of this revision will not interfere with attainment and reasonable further progress or any other applicable Federal requirement, as required by section 110(l) of the CAA. Accordingly, we propose to approve the removal of existing paragraph (a)(3), submitted December 15, 1995, and July 22, 1998.</FP>
        <P>e. The removal of existing paragraph (a)(4).</P>
        <P>This paragraph required that upon renewal the facility will continue to use the control technology determined by the Executive Director to be economically reasonable and technically practicable considering the age of the facility and the impact of its emissions on the surrounding area. Texas submitted the removal of paragraph (a)(4) on December 15, 1995, and July 22, 1998. EPA believes that this provision is redundant because the SIP already provides for this substantive requirement at 30 TAC 116.311(a)(2) and 30 TAC 116.111(a)(2)(C). Section 30 TAC 116.311(a)(2) provides that upon renewal, the facility is being operated in accordance with all requirements and conditions of the existing permit, including representations in the application for permits to construct and subsequent amendments, and any previously granted renewal. Therefore, the SIP-approved requirements 30 TAC 116.311(a)(2) require that upon renewal, a facility will continue to meet the requirements of 30 TAC 116.111(a)(2)(C). This SIP rule requires that a proposed facility will utilize Best Available Control Technology (BACT), with consideration given to technical practicability and economic reasonableness of reducing or eliminating the emissions from the facility. Because the proposed removal of paragraph (a)(4) merely is the removal of a redundant requirement, it is not a relaxation of the SIP. Therefore, approval of the removal of 30 TAC 116.311(a)(4) will not interfere with attainment and reasonable further progress or any other applicable Federal requirement, as required by section 110(l) of the CAA.</P>
        <P>The removal of paragraph (a)(4) also removes a provision that allows director discretion relating to the control technology that could be utilized at a facility following renewal. Further, the TCEQ maintains the authority to impose, as a condition of renewal, additional requirements that it determines to be economically reasonable and technically practicable considering the age of the facility and the impact of its emissions on the surrounding area, as provided in the submitted revisions related to 30 TAC 116.311(b) (which is evaluated in section III.B.3.i of this preamble). Accordingly, we propose to approve the removal of existing paragraph (a)(4), submitted December 15, 1995, and July 22, 1998.</P>
        <P>f. Revisions to currently submitted paragraphs (a)(3) and (a)(4).</P>

        <P>These paragraphs are currently approved as paragraphs (a)(5) and (a)(6). These paragraphs require that upon renewal, the facility must continue to meet the applicable requirements of the New Source Performance Standards (required under section 111 of the Act and 40 CFR part 60) and the National Emission Standards for Hazardous Air Pollutants (required under section 112 of the Act and 40 CFR part 61). These<PRTPAGE P="32338"/>paragraphs were redesignated to paragraphs (a)(2) and (a)(3) with non-substantive changes in revisions submitted December 15, 1995, and July 22, 1998, and were again redesignated to paragraphs (a)(3) and (a)(4) in a revision submitted September 4, 2002, with no substantive changes. These changes are non-substantive revisions to the existing SIP. Accordingly, we propose to approve the redesignations and non-substantive changes to these paragraphs as submitted December 15, 1995; July 22, 1998; and September 4, 2002.</P>
        <P>g. Addition of new paragraph (a)(5).</P>
        <P>This paragraph was submitted as paragraph (a)(4) on July 22, 1998, and then recodified to paragraph (a)(5), as submitted September 4, 2002. This paragraph requires that upon renewal, the facility must continue to meet the applicable requirements of the maximum achievable control technology standard as listed under 40 CFR Part 63, promulgated by EPA under the authority of section 112 of the CAA, or as listed under 30 TAC Chapter 113, Subchapter C of this title (relating to National Emissions Standards for Hazardous Air Pollutants for Source Categories) (FCAA § 112, 40 CFR 63). This paragraph ensures that upon renewal the facility continues to meet the requirements of the current SIP at 30 TAC 116.111(a)(2)(F) which requires permitted facilities to comply with the requirements of 40 CFR part 63. Accordingly, we propose to approve the addition of paragraph (a)(5) as submitted December 15, 1995; July 22, 1998; and September 4, 2002.</P>
        <P>h. Addition of new subsection (b).</P>
        <P>Texas submitted subsection (b) on December 15, 1995, and July 22, 1998. This section provides that in addition to the requirements in subsection (a) of this section, if the TCEQ determines it necessary to avoid a condition of air pollution or to ensure compliance with otherwise applicable Federal or state air quality control requirements, then: (1) The applicant may be required to submit additional information regarding the emissions from the facility and their impacts on the surrounding area; and (2) the TCEQ shall impose as a condition for renewal those requirements the Executive Director determines to be economically reasonable and technically practicable considering the age of the facility and the impact of its emissions on the surrounding area. This new subsection provides the Executive Director of the TCEQ with authority to require additional information and to require additional requirements above and beyond the requirements stipulated in subsection (a) whenever the Executive Director deems such additional measures are necessary. EPA has already approved subsection (a) (as adopted by the State on April 6, 1994) as meeting the requirements of the Act and 40 CFR part 51. Because the requirements in subsection (b) are in addition to the requirements in subsection (a) of this section, and because EPA has approved subsection (a), subsection (b) can only be used to impose additional measures when the Executive Director deems them necessary. Subsection (b) does not authorize the Executive Director to use the permit renewal process to relax terms and conditions of the existing permit. Such relaxations of the existing permit must be authorized through the SIP-approved procedures for changing a permit under 30 TAC 116, Chapter 116, Subchapter B—New Source Review Permits.<SU>3</SU>
          <FTREF/>Further, the addition of subparagraph (b) provides a mechanism to ensure that upon renewal, the permit continues to meet the approved SIP requirements at 30 TAC 116.111(a)(2)(A)(1) which requires the initial permit must “comply with all rules and regulations of the commission and with the intent of the TCAA, including protection of the health and property of the public.” The addition of subsection (b) provides TCEQ with a mechanism to impose additional requirements at renewal when TCEQ deems it necessary to address changes in air quality or changes to applicable Federal and state requirements that may occur after issuance of the initial permit. We therefore find that the submitted revision to add subsection (b) to 30 TAC 116.311 meets section 110(a)(2)(C) of the Act and 40 CFR part 51; and does not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act. Accordingly, we propose to approve the addition of the new subsection (b) to the SIP.</P>
        <FTNT>
          <P>
            <SU>3</SU>Also see the SIP approved rule at 30 TAC 116.315(c) which provides that a renewal application may be submitted at the same time as an amendment application to modify an existing facility as long as it is submitted no more than three years before the permit's expiration date and the amendment is subject to public notice requirements.</P>
        </FTNT>
        <P>i. Revisions to subsection (c).</P>
        <P>This provision is currently approved as subsection (b). This subsection requires that upon renewal, the facility shall continue to meet the requirements under the undesignated heading in Subchapter B relating to compliance history. This provision was redesignated to subsection (c) with revisions, submitted December 15, 1995, and July 22, 1998. The submitted revisions include changing the citations to refer to the Compliance History provisions to refer to the SIP-approved requirement under 30 TAC 116.120 through 116.126 under Subchapter B, Division 2—Compliance History. The changes also include clarifications that failure to demonstrate compliance with the Compliance History requirements shall result in the renewal not being granted. It further changes the rule to provide that if a contested case hearing has not been requested, the Executive Director, not the staff, must notify the applicant of intent to recommend denial of an application for permit renewal if the TCEQ finds that violations of the compliance history constitute a recurring pattern of egregious conduct which demonstrates a consistent disregard for the regulatory process, including failure to make a timely and substantial attempt to correct the violations. Accordingly, we propose to approve the redesignation of subsection (b) to subsection (c) and the revisions thereto as submitted December 15, 1995, and July 22, 1998.</P>
        <HD SOURCE="HD2">C. Section 30 TAC 116.314—Review Schedule</HD>
        <HD SOURCE="HD3">1. What is the background of 30 TAC 116.314?</HD>
        <P>The currently approved provisions for 30 TAC 116.314 were submitted to EPA on August 31, 1993. EPA approved the submitted revisions on March 10, 2006 (71 FR 12285). These revisions became effective on May 9, 2006.</P>
        <HD SOURCE="HD3">2. What did Texas submit for 30 TAC 116.314?</HD>
        <P>Since EPA's last approval for this section, TCEQ has submitted two SIP revisions to EPA for this section on December 15, 1995, and July 22, 1998. In this action, we are proposing to approve the revisions of the existing provisions of section 116.314. The revisions submitted to this section include the following:</P>
        <P>• Reorganization of subsection (a) into subsections (a) and (b) and redesignation of existing subsections (b) and (c) to subsections (c) and (d).</P>
        <P>• Non-substantive revisions to the reorganized subsections (a) and (b).</P>
        <P>• Revisions to subsection (c) as recodified.</P>
        <P>• Non-substantive revisions to subsection (d) as recodified.</P>
        <HD SOURCE="HD3">3. What is EPA's evaluation of the submitted revisions to 30 TAC 116.314?</HD>
        <P>The revisions to 30 TAC 116.314 are evaluated and addressed in this proposed action as described below:</P>
        <P>a. Revisions to subsections (a) and (b).<PRTPAGE P="32339"/>
        </P>
        <P>The revisions submitted July 22, 1998, revised and reorganized subsection (a) into subsections (a) and (b). These revisions include clarifying amendments which streamline and reorganize the requirements of subsections (a) and (b). The submitted changes are non-substantive. Accordingly, we propose to approve subsections (a) and (b) as submitted December 15, 1995, and July 22, 1998.</P>
        <P>b. Revisions to subsection (c).</P>

        <P>These provisions are currently approved as subsection (b). As approved, this subsection provides that in the event that the permit holder fails to satisfy the requirements for corrective action by the deadline specified in the report filed by the TCEQ, the applicant shall be required to show cause in a contested case proceeding why the permit should not expire. The proceeding will be pursuant to the requirements of the Administrative Procedure and Texas Register Act, Article 6252-13a, V.T.C.S. This subsection was recodified to subsection (c) in the revisions submitted December 15, 1995, and July 22, 1998. The submitted revisions update the agency name and the statutory citation relating to contested case hearings and referred to the contested case hearing provisions in 30 TAC Chapters 1, 55, and 80. The submitted revision to 30 TAC 116.314(c) includes specific cross-references to 30 TAC Chapters 1, 55, and 80, which relate to Purpose of Rules, General Provisions; Request for Contested Case Hearings; Public Comment; and Contested Case Hearings. In contrast, the current SIP refers to the Contested Case Hearing Process without cross references to specific rules relating to Contested Case Hearings. Although the revision provides references to the specific rules relating to Contested Case Hearings, the revision<E T="03">does not</E>make substantive changes to the requirements of the existing SIP. Texas's use of the Contest Hearing Process in this context in both the current SIP and the submitted revisions is to inform the permit applicant of the availability of the contested case hearing but does not incorporate the specific requirements of Chapters 1, 55, and 80 into the SIP. Further, the submitted revision to 30 TAC 116.314(c) meets the requirements of section 110(a)(2)(C) of the Act and 40 CFR part 51, does not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act. Accordingly, EPA proposes to approve the revisions to subsection (c) as submitted December 15, 1995, and July 22, 1998.</P>
        <P>d. Revisions to subsection (d).</P>
        <P>These provisions are currently approved as subsection (c) and relate to the effective date of the existing permit. This subsection was revised and recodified to subsection (d) in revisions submitted December 15, 1995, and July 22, 1998. These revisions include clarifying amendments which streamline the requirements relating to Permit Renewals. The submitted changes are non-substantive. Accordingly, we propose to approve the revision to subsection (d) as submitted December 15, 1995, and July 22, 1998.</P>
        <HD SOURCE="HD1">IV. Proposed Action</HD>
        <P>Today, EPA proposes to approve the following revisions to the Texas SIP:</P>
        <P>• Revisions to 30 TAC 116.310—Notification of Permit Holder—submitted December 15, 1995, and July 22, 1998.</P>
        <P>• Revisions to 30 TAC 116.311—Permit Renewal Application—submitted December 15, 1995; July 22, 1998; and September 4, 2002; as follows:</P>
        <P>○ Addition of new paragraph (a)(1);</P>
        <P>○ Removal of existing paragraphs (a)(1), (a)(3), and (a)(4);</P>
        <P>○ Revisions to and redesignation of existing paragraphs (a)(5) and (a)(6) to paragraphs (a)(3) and (a)(4), respectively;</P>
        <P>○ Addition of new paragraph (a)(5);</P>
        <P>○ Addition of new subsection (b); and</P>
        <P>○ Revisions to and redesignation of existing subsection (b) to subsection (c)</P>
        <P>• Revisions to 30 TAC 116.314—Review Schedule—submitted December 15, 1995, and July 22, 1998, as follows:</P>
        <P>○ The revisions to and reorganization of existing subsection (a) to subsections (a) and (b); and</P>
        <P>○ The revisions to and redesignation of existing subsections (b) and (c) to subsections (c) and (d).</P>
        <P>Much of this SIP revision re-organizes and makes non-substantive changes to the Texas renewals program. This revision also revises the SIP by adding a requirement to ensure that permits that pre-date TCEQ's rule change to regulate dockside emissions are required at renewal to ensure all dockside emissions comply with the statute and regulations. The revision also removed the following three requirements from the renewals process: (1) Upon renewal the emissions from the facility will comply with all applicable specifications and requirements in the Texas Air Control Board (TACB) rules and the Texas Clean Air Act (TCAA); (2) upon renewal the facility will continue to have appropriate means to measure the emission of significant air contaminants as determined necessary by the Executive Director; and (3) upon renewal the facility will continue to use the control technology determined by the Executive Director to be economically reasonable and technically practicable considering the age of the facility and the impact of its emissions on the surrounding area. We believe that the removal of these provisions is approvable because these requirements are provided elsewhere in the Texas SIP; and therefore, their deletion will not interfere with attainment and reasonable further progress of the NAAQS or any other applicable requirement, as required by section 110(l) of the CAA.</P>
        <P>Final action on these revisions on or before October 31, 2011, will meet EPA's obligation on the Permit Renewals component of the May 21, 2009, Consent Decree between EPA and the Business Coalition for Clean Air Appeal Group, Texas Association of Business, and Texas Oil and Gas Association.</P>
        <P>EPA proposes to take no action on the following revisions to 30 TAC 116.311, December 15, 1995; July 22, 1998; and September 4, 2002:</P>
        <P>• Severable revisions to paragraph (a)(2), which relate to the Qualified Facilities Program. Today, we propose to retain the currently approved provisions of paragraph (a)(2) in the SIP as adopted by Texas on April 6, 1994, approved March 10, 2006 (71 FR 12285). We will address the revisions to paragraph (a)(2) in connection with a separate SIP submittal that revises the Qualified Facilities Program, submitted October 5, 2010. EPA disapproved Texas Qualified Facilities Program on April 14, 2010 (75 FR 19467). Under the CAA, EPA's statutory deadline to take action on the revised Qualified Facilities Program is April 5, 2012.</P>
        <HD SOURCE="HD1">V. Statutory and Executive Order Reviews</HD>
        <P>Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this notice merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:</P>

        <P>• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under<PRTPAGE P="32340"/>Executive Order 12866 (58 FR 51735, October 4, 1993);</P>

        <P>• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501<E T="03">et seq.</E>);</P>

        <P>• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601<E T="03">et seq.</E>);</P>
        <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
        <P>• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
        <P>• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);</P>
        <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);</P>
        <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and</P>
        <P>• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).</P>
        
        <FP>In addition, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on Tribal governments or preempt Tribal law.</FP>
        <LSTSUB>
          <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
          <P>Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
        </LSTSUB>
        <AUTH>
          <HD SOURCE="HED">Authority:</HD>
          <P>42 U.S.C. 7401<E T="03">et seq.</E>
          </P>
        </AUTH>
        <SIG>
          <DATED>Dated: May 20, 2011.</DATED>
          <NAME>Al Armendariz,</NAME>
          <TITLE>Regional Administrator, Region 6.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13872 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6560-50-P</BILCOD>
    </PRORULE>
    <PRORULE>
      <PREAMB>
        <AGENCY TYPE="N">GENERAL SERVICES ADMINISTRATION</AGENCY>
        <CFR>41 CFR Parts 301-11, 302-2, 302-3, and 302-17</CFR>
        <DEPDOC>[FTR Case 2009-307; Docket 2009-0013; Sequence 1]</DEPDOC>
        <RIN>RIN 3090-AI95</RIN>
        <SUBJECT>Federal Travel Regulation; Temporary Duty (TDY) Travel Allowances (Taxes); Relocation Allowances (Taxes)</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Office of Governmentwide Policy (OGP), General Services Administration (GSA).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Proposed rule.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>GSA is proposing to amend the Federal Travel Regulation (FTR) by incorporating recommendations of the Governmentwide Relocation Advisory Board (GRAB) concerning calculation of reimbursements for taxes on relocation expenses. In addition, this proposed rule alters the process for calculating reimbursements for taxes on extended temporary duty (TDY) benefits to correct errors and to align that process with the proposed changes to the relocation income tax process.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>Interested parties should submit comments in writing on or before August 5, 2011 to be considered in the formulation of a final rule.</P>
        </EFFDATE>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit comments identified by FTR case 2009-307 by any of the following methods:</P>
          <P>•<E T="03">Regulations.gov: http://www.regulations.gov.</E>
          </P>
          <P>Submit comments via the Federal eRulemaking portal by inputting “FTR Case 2009-307” under the heading “Comment or Submission.” Select the link “Send a Comment or Submission” that corresponds with FTR Case 2009-307. Follow the instructions provided to complete the “Public Comment and Submission Form.” Please include your name, company name (if any), and “FTR Case 2009-307” on your attached document.</P>
          <P>•<E T="03">Fax:</E>202-501-4067.</P>
          <P>•<E T="03">Mail:</E>General Services Administration, Regulatory Secretariat (MVCB), 1275 First Street, NE., Room 783E, ATTN: Hada Flowers, Washington, DC 20417.</P>
          <P>
            <E T="03">Instructions:</E>Please submit comments only and cite FTR case 2009-307 in all correspondence related to this case. All comments received will be posted without change to<E T="03">http://www.regulations.gov,</E>including any personal information provided.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>The General Services Administration, Regulatory Secretariat (MVCB), 1275 First Street, NE., Washington, DC 20417, (202) 501-4755, for information pertaining to status or publication schedules. For clarification of content, contact Mr. Ed Davis, Office of Governmentwide Policy (MT), General Services Administration, at (202) 208-7638 or e-mail at<E T="03">ed.davis@gsa.gov.</E>Please cite FTR case 2009-307.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">A. Request for Input on the Final Effective Date</HD>
        <P>GSA recognizes that implementing the final rule that will result from this proposed rule will be challenging and time-consuming, both for Federal agencies and software providers. To help set a final effective date that allows adequate time to implement the final rule, GSA requests comments from affected parties on how much time they will need to change their systems and processes to implement the eventual final rule.</P>
        <HD SOURCE="HD1">B. Background</HD>

        <P>The GSA Office of Governmentwide Policy seeks to incorporate best practices from Federal agencies and the private sector into the policies that GSA issues. To this end, GSA created the GRAB, consisting of Government and private industry relocation experts, to examine Government relocation policy. The GRAB was chartered under the Federal Advisory Committee Act on July 9, 2004, and it submitted its “Findings and Recommendations” on September 15, 2005. The GRAB “Findings and Recommendations” and corresponding documents may be accessed at GSA's Web site at<E T="03">http://www.gsa.gov/grab.</E>The GRAB made a number of recommendations with regard to taxes, and GSA has developed this proposed rule in response to those recommendations.</P>
        <P>GSA has worked with the Executive Relocation Steering Committee (ERSC), an interagency group chartered by GSA, to analyze the GRAB recommendations regarding taxes. The first product of the analysis by the ERSC was a set of four principles:</P>
        <P>• “Substantially all”—Federal agencies are required by 5 U.S.C. 5724b to reimburse “substantially all” of the additional income taxes incurred by employees as a result of relocation and to reimburse “all” of the taxes imposed on any reimbursement for taxes.</P>

        <P>• Fair and equitable—In personnel matters, the Government seeks to treat all employees fairly and equitably. A key piece of this is transparency. Everyone must be able to see and understand how the benefits are being computed. Another key piece is seeking<PRTPAGE P="32341"/>to treat all civilian transferees equally, regardless of grade level.</P>
        <P>• Relative simplicity—The tax process is necessarily complex because relocation has so many parts. However, it is important to keep this process as simple as possible, so that agencies can and will perform all of the calculations accurately, so that employees can verify the calculations, and so that employees will be more likely to believe that they are being treated fairly and equitably.</P>
        <P>• Minimizing cost—It is, of course, very important to balance the three objectives above against the overall cost of reimbursing employees for the taxes that they incur. It is important, therefore, to seek to limit reimbursement to “substantially all” of each transferee's tax liability, to the extent that this can be done without making the process overly complex.</P>
        <HD SOURCE="HD1">C. Major Changes in This Proposed Rule</HD>
        <P>This proposed rule completely replaces FTR part 302-17. It also removes FTR part 301-11, subpart E, and it replaces FTR part 301-11, Subpart F, which regulates taxes involved in extended TDY benefits.</P>
        <P>The major changes in this proposed rule are:</P>
        <P>
          <E T="03">Taxes on extended TDY benefits</E>—The existing FTR part 301-11, subpart E, addresses only tax years 1993 and 1994 and is therefore obsolete. FTR part 301-11, subpart F, includes several substantial errors and does not agree with either the existing FTR part 302-17 or this proposed rule. This proposed rule deletes part 301-11, subpart E, and it replaces part 301-11, subpart F in its entirety. This proposed rule also eliminates the lump sum process for reimbursing taxes on extended TDY benefits. This process is seldom used and, therefore, creates more confusion than benefit.</P>
        <P>
          <E T="03">Question and answer format</E>—This proposed rule puts part 302-17 into question and answer format to conform to the remainder of the FTR. GSA notes that the GRAB recommended that GSA move in the other direction, taking all of the FTR back to its old format. GSA has considered and rejected this GRAB recommendation. GSA continues to believe that the question and answer format is easier to read and understand for the large majority of users.</P>
        <P>
          <E T="03">Eliminating use of two tables for Federal tax rates</E>—GSA examined the tax tables for the past seven years and determined that the difference in tax rates from year to year is not large enough to justify formulas complex enough to account for year-to-year changes in Federal tax rates.</P>
        <P>
          <E T="03">Standardizing usage of the terms “withholding tax allowance” (WTA) and “relocation income tax allowance” (RITA)</E>—The existing part 302-17 is not entirely clear in its use of these two terms. The proposed rule seeks to clarify these terms and, to this end, it changes the title of part 302-17 to “Taxes on Relocation Expenses.”</P>
        <P>
          <E T="03">Fraudulent claims</E>—The existing part 302-17 includes a paragraph, at § 302-17.10(c), about fraudulent claims made against the United States, especially in the context of the “Statement of Income and Tax Filing Status.” The statutes on fraudulent claims remain in effect and unchanged. However, these statutes apply to the entire relocation process, not just reimbursement for taxes on relocation expenses, and GSA therefore has added a new section to FTR part 302-2 to address fraudulent claims made at any point during the relocation reimbursement process. This new section directly mirrors section 301-52.12 covering fraudulent claims with regards to TDY benefits.</P>
        <P>
          <E T="03">New definitions</E>—The proposed rule includes definitions for 13 terms in a glossary that is specific to part 302-17. Many of these terms are defined in the text of the existing part 302-17; the proposed rule gathers these 13 definitions into one place for easy reference in the new section 302-17.1.</P>
        <P>
          <E T="03">Limitations and Federal income tax treatments</E>—The proposed rule provides a table in section 302-17.8 that summarizes allowances, limitations, and tax treatment for each relocation reimbursement, allowance or direct payment to a vendor provided by the FTR.</P>
        <P>
          <E T="03">Correcting the taxability of household goods transportation expenses</E>—The existing section 302-17.3(b) states that the expenses for transportation of household goods (HHG) are taxable. This was true when the existing FTR 302-17 was published. However, in 1993 the IRC section on fringe benefits was amended to exclude from income certain moving expenses that are reimbursed and otherwise would be deductible. At the same time the IRC was amended to make fewer moving expenses deductible. One result was that the HHG shipment remained as a deductible expense.</P>
        <P>
          <E T="03">Correcting the withholding rate for supplemental wages</E>—The withholding rate of 28 percent for supplemental wages used in the current FTR 301-11, subpart F and 302-17.7 is incorrect. The correct rate is 25 percent, and this is the rate used in this proposed rule, at § 302-17.24. This rate is scheduled to revert to 28 percent on January 1, 2011, absent legislative action. If and when this rate changes, GSA will correct the new part 302-17 to reflect the change.</P>
        <P>
          <E T="03">Allowing a one-year RITA process</E>—The GRAB's “Findings and Recommendations” clearly says that a one-year RITA process is the standard in the private sector because it is quicker and simpler. The GRAB strongly recommended that the Federal government adopt a one-year process. In addition to its complexity, the existing two-year process for calculating taxes on relocation expenses creates a burden for many lower-grade transferees, because they are more likely to be required, in the second year, to repay an over-reimbursement in the first year. On the other hand, discussions with Federal agencies have made it clear that moving to a one-year process will be challenging at best, and many are reluctant to move in that direction. In addition, as some have noted, the two-year process does result in a somewhat more accurate reflection of the actual tax impact on the employee. Therefore, this proposed rule offers the one-year RITA process to agencies as an option, alongside the existing two-year process. It also includes, at new section 302-17.103, a short discussion of the benefits and drawbacks of the one-year and two-year processes. See also new sections 302-17.32, 302-17.33, and subparts F and G.</P>
        <P>
          <E T="03">Making the WTA optional</E>—A number of Federal agencies have made the WTA optional to the employee. Nothing in tax law or existing regulations prohibits this practice, and in some cases declining the WTA may be advantageous to the employee. This proposed rule explicitly gives the agencies permission to make the WTA optional and provides guidance and explanation for both the agency and the employee.</P>
        <P>
          <E T="03">Moving from earned income to taxable income</E>—As the ERSC reviewed the GRAB's recommendations, it recognized that using taxable income (instead of using earned income like the existing part 302-17), would provide a simpler process and would bring the taxes reimbursement calculation closer to the target of “substantially all.” Moving to taxable income resolves several of the issues that the GRAB raised, including issues with capital gains and self-employment income. See new sections 302-17.40, 302-17.50, and 302-17.63 for information on how taxable income is used.</P>
        <P>
          <E T="03">Eliminating the Government-unique tax tables</E>—Moving to taxable income will also make it unnecessary for GSA to publish special tax tables each year. Transferees and agencies will be able to use the tables published by the Internal Revenue Service (IRS) and state and local tax authorities.<PRTPAGE P="32342"/>
        </P>
        <P>
          <E T="03">Failure to file the “Statement of Income and Tax Filing Status” in a timely manner</E>—The existing § 302-17.7(e)(2) makes the entire WTA an excess payment if the employee fails to file the statement or the RITA claim in a timely manner. Because the WTA is an advance payment on the employee's reimbursable income tax expenses, agencies are entitled to recover it if an employee fails to properly document their income taxes. Therefore, this proposed rule continues these requirements on the employee and the agency, except in the case of an employee who declines the WTA. In this case, if the employee fails to file the “Statement of Income and Tax Filing Status” and/or the RITA claim in a timely manner, this proposed rule allows the agency to close the file without paying the RITA. See new sections 302-17.53, 302-17.65, and 302-17.102.</P>
        <P>
          <E T="03">Recalculation of RITA</E>—The existing part 302-17 makes no provision for the employee to request recalculation. Most private sector companies do allow employees to request recalculation, at least in some circumstances, though the percentage of private sector employees who do request recalculation is small. The proposed rule makes it possible for Federal employees to request recalculation, provided they filed and/or amend their “Statement of Income and Tax Filing Status” in a timely manner. See the new section 302-17.33.</P>
        <P>
          <E T="03">Agency responsibilities</E>—The existing part 302-17 mentions some agency responsibilities in the context of other provisions. The proposed rule, in conformity with the rest of the FTR, lists the agency responsibilities together in the new subpart H.</P>
        <P>
          <E T="03">Information about state and local tax laws</E>—GSA informally circulated a draft version of this proposed rule to various Federal agencies asking for input. Several agencies objected to what they thought were new or additional burdens stemming from requirements to know and utilize state and local tax laws. However, current section 302-17.10(b)(2) already places this requirement on agencies, stating “* * * is incumbent upon the appropriate agency officials to become familiar with the state and local tax laws that affect their transferring employees.” In short, this proposed rule is not imposing any new requirements on agencies regarding knowledge of state and local tax law. At the same time, this rule carries forward from the current 302-17 the requirement that the employee find and provide the applicable state and local marginal tax rates.</P>
        <HD SOURCE="HD1">D. Changes to the Current FTR</HD>
        <P>This proposed rule—</P>
        <P>• Deletes part 301-11, subpart E.</P>
        <P>• Replaces part 301-11, subpart F in its entirety.</P>
        <P>• Adds new § 302-2.7.</P>
        <P>• Replaces one sentence in § 302-3.502(b).</P>
        <P>• Replaces part 302-17 in its entirety.</P>
        <HD SOURCE="HD1">E. Executive Order 12866 and Executive Order 13563</HD>
        <P>Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.</P>
        <HD SOURCE="HD1">F. Regulatory Flexibility Act</HD>
        <P>This proposed rule is not required to be published in the<E T="04">Federal Register</E>for notice and comment as per the exemption specified in 5 U.S.C. 553(a)(2); therefore, the Regulatory Flexibility Act, 5 U.S.C. 601,<E T="03">et seq.,</E>does not apply. However, this proposed rule is being published to provide transparency in the promulgation of Federal policies.</P>
        <HD SOURCE="HD1">G. Paperwork Reduction Act</HD>

        <P>The Paperwork Reduction Act does not apply because the proposed changes to the Federal Travel Regulation do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501,<E T="03">et seq.</E>
        </P>
        <HD SOURCE="HD1">H. Small Business Regulatory Enforcement Fairness Act</HD>
        <P>This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.</P>
        <LSTSUB>
          <HD SOURCE="HED">List of Subjects in 41 CFR Parts 301-11, 302-2, 302-3, and 302-17</HD>
          <P>Government employees, Travel and transportation expenses, Income taxes.</P>
        </LSTSUB>
        <SIG>
          <DATED>Dated: March 14, 2011.</DATED>
          <NAME>Kathleen Turco,</NAME>
          <TITLE>Associate Administrator.</TITLE>
        </SIG>
        <P>For the reasons set forth in the preamble, under 5 U.S.C. 5701-5739, GSA proposes to amend 41 CFR parts 301-11, 302-2, 302-3, and 302-17 as set forth below:</P>
        <PART>
          <HD SOURCE="HED">PART 301-11—PER DIEM EXPENSES</HD>
          <P>1. The authority for part 301-11 continues to read as follows:</P>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>5 U.S.C. 5707.</P>
          </AUTH>
          <SUBPART>
            <HD SOURCE="HED">Subpart E—[Removed and Reserved]</HD>
          </SUBPART>
          <P>2. Remove and reserve subpart E.</P>
          <P>3. Revise subpart F to read as follows:</P>
          <CONTENTS>
            <SUBPART>
              <HD SOURCE="HED">Subpart F—Taxes on Extended TDY Benefits</HD>
              <SECHD>Sec.</SECHD>
              <SECTNO>301-11.601</SECTNO>
              <SUBJECT>What is a taxable extended TDY assignment?</SUBJECT>
              <SECTNO>301-11.602</SECTNO>
              <SUBJECT>What factors should my agency consider in determining whether to authorize extended TDY?</SUBJECT>
              <SECTNO>301-11.603</SECTNO>
              <SUBJECT>What are the tax consequences of extended TDY?</SUBJECT>
              <SECTNO>301-11.604</SECTNO>
              <SUBJECT>What are the procedures for calculation and reimbursement of my WTA and ETTRA for taxable extended TDY?</SUBJECT>
              <SECTNO>301-11.605</SECTNO>
              <SUBJECT>When should I file my “Statement of Income and Tax Filing Status” for my taxable extended TDY assignment?</SUBJECT>
            </SUBPART>
          </CONTENTS>
          <SUBPART>
            <HD SOURCE="HED">Subpart F—Taxes on Extended TDY Benefits</HD>
            <SECTION>
              <SECTNO>§ 301-11.601</SECTNO>
              <SUBJECT>What is a taxable extended TDY assignment?</SUBJECT>

              <P>A taxable extended TDY assignment is a TDY assignment that continues for so long that, under the IRC the employee is no longer considered “temporarily away from home.” The IRC, at 26 U.S.C. 162(a), states: “* * * the taxpayer shall not be treated as being temporarily away from home during any period of employment if such period exceeds 1 year.” You are no longer “temporarily away from home” as of the date that you and/or your agency recognize that your assignment will exceed one year. That is, as soon as you recognize that your assignment will exceed one year, you must notify your agency of that fact, and they must change your status immediately. Similarly, as soon as your agency recognizes that your assignment will exceed one year, your agency must notify you of that fact and change your status. The effective date of this status change is the date on which it was recognized that you are no longer “temporarily away from home” as defined in the IRC.<PRTPAGE P="32343"/>
              </P>
              <P>(a) If you believe that your temporary duty assignment may exceed one year, you should carefully study IRS Publication 463, “Travel, Entertainment, Gift, and Car Expenses,” to determine whether you are or will be considered “temporarily away from home” under this provision. If you are not or will not be considered “temporarily away from home” under this provision, then you are on taxable extended TDY.</P>
              <P>(b) The IRC makes an exception for certain Federal personnel involved in investigation or prosecution of a Federal crime. Specifically, 26 U.S.C. 162(a), continues: “The [above quotation from 26 U.S.C. 162(a)] shall not apply to any Federal employee during any period for which such employee is certified by the Attorney General (or the designee thereof) as traveling on behalf of the United States in temporary duty status to investigate or prosecute, or provide support services for the investigation or prosecution of, a Federal crime.”</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 301-11.602</SECTNO>
              <SUBJECT>What factors should my agency consider in determining whether to authorize extended TDY?</SUBJECT>
              <P>Your agency should consider the factors discussed in § 302-3.502 of this Subtitle in determining whether to authorize extended TDY.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 301-11.603</SECTNO>
              <SUBJECT>What are the tax consequences of extended TDY?</SUBJECT>
              <P>(a) If you are on a taxable extended TDY assignment, then all allowances and reimbursements for travel expenses, plus all travel expenses that the Government pays directly on your behalf in connection with your TDY assignment, are taxable income to you. This includes all allowances, reimbursements, and direct payments to vendors from the day that you or your agency recognized that your extended TDY assignment is expected to exceed one year, as explained in § 301-11.601.</P>
              <P>(b) Your agency will reimburse you for substantially all of the income taxes that you incur as a result of your taxable extended TDY assignment. This reimbursement consists of two parts:</P>
              <P>(1) The Withholding Tax Allowance (WTA). See part 302-17, subpart B of this Subtitle for information on the WTA; and</P>
              <P>(2) The “Extended TDY Tax Reimbursement Allowance” (ETTRA) (in previous editions of the FTR this was known as the “Income Tax Reimbursement Allowance”).</P>
              <P>(c) The WTA and ETTRA for taxable extended TDY assignments cover only the TDY benefits described in FTR Chapter 301, Subchapter B. On an extended TDY assignment, you are not eligible for the other benefits that you would have received if your agency had permanently relocated you.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 301-11.604</SECTNO>
              <SUBJECT>What are the procedures for calculation and reimbursement of my WTA and ETTRA for taxable extended TDY?</SUBJECT>
              <P>(a) If your agency knows from the beginning of your TDY assignment that your assignment qualifies as taxable extended TDY, then your agency will withhold an amount as a WTA and pay that as withholding tax to the IRS until your extended TDY assignment ends. The WTA itself is taxable income to you, so your agency increases, or “grosses-up,” the amount of the WTA, using a formula to reimburse you for the additional taxes on the WTA.</P>
              <P>(b) If your agency realizes during a TDY assignment that you will incur taxes (because, for example, the TDY assignment has lasted, or is going to last, longer than originally intended), then your agency will compute the WTA for all taxable benefits received since the date it was recognized that you are no longer “temporarily away from home” (See § 302-11.601 for more information on the meaning of “temporarily away from home”). Your agency will pay that amount to the IRS, and then will begin paying WTA to the IRS until your extended TDY assignment ends.</P>
              <P>(c) For your ETTRA, your agency will use the same one-year or two-year process that it has chosen to use for the relocation income tax allowance (RITA).</P>
              <P>(d) See part 302-17 of this subtitle for additional information on the WTA and RITA processes.</P>
              <NOTE>
                <HD SOURCE="HED">Note to § 301-11.604:</HD>
                <P>If your agency chooses to offer you the choice, the WTA is optional to you. See §§ 302-17.61 through 302-17.69.</P>
              </NOTE>
            </SECTION>
            <SECTION>
              <SECTNO>§ 301-11.605</SECTNO>
              <SUBJECT>When should I file my “Statement of Income and Tax Filing Status” for my taxable extended TDY assignment?</SUBJECT>
              <P>You should file your “Statement of Income and Tax Filing Status” for your taxable extended TDY assignment at the beginning of your extended TDY assignment or, as soon as you or your agency realizes that your TDY assignment will incur taxes. You should provide the same information as the sample “Statements of Income and Tax Filing Status” shown in part 302-17, subpart F (one-year process) or subpart G (two-year process) of this Subtitle.</P>
            </SECTION>
          </SUBPART>
        </PART>
        <PART>
          <HD SOURCE="HED">PART 302-2—EMPLOYEE ELIGIBILITY REQUIREMENTS</HD>
          <P>4. The authority for part 302-2 continues to read as follows:</P>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>5 U.S.C. 5738; 20 U.S.C. 905(a).</P>
          </AUTH>
          <SECTION>
            <SECTNO>§§ 302-2.7—302-2.22</SECTNO>
            <SUBJECT>[redesignated as §§ 302-2.8—302-2.23]</SUBJECT>
            <P>5. Redesignate §§ 302-2.7—302-2.22 as §§ 302-2.8—302-2.23, respectively, and add new § 302-2.7 to read as follows:</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 302-2.7</SECTNO>
            <SUBJECT>What happens if I attempt to defraud the Government?</SUBJECT>
            <P>If you attempt to defraud the Government:</P>
            <P>(a) You forfeit reimbursement pursuant to 28 U.S.C. 2514; and</P>
            <P>(b) You may be subject under 18 U.S.C. 287 and 1001 to one, or both, of the following:</P>
            <P>(1) A fine of not more than $10,000, and/or</P>
            <P>(2) Imprisonment for not more than 5 years.</P>
          </SECTION>
        </PART>
        <PART>
          <HD SOURCE="HED">PART 302-3—RELOCATION ALLOWANCES BY SPECIFIC TYPE</HD>
          <P>6. The authority for part 302-3 continues to read as follows:</P>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>5 U.S.C. 5738; 20 U.S.C. 905(a).</P>
          </AUTH>
          
          <P>7. Amend § 302-3.502 by revising the second sentence in paragraph (b) to read as follows:</P>
          <SECTION>
            <SECTNO>§ 302-3.502</SECTNO>
            <SUBJECT>What factors should we consider in determining whether to authorize a TCS for a long-term assignment?</SUBJECT>
            <STARS/>
            <P>(b) * * * The Withholding Tax Allowance and the Extended TDY Tax Reimbursement Allowance allow for the reimbursement of Federal, state, and local income taxes incurred as a result of taxable extended temporary duty assignments (see §§ 301-11.601—301-11.605 of this Subtitle). * * *</P>
            <STARS/>
            <P>8. Revise part 302-17 to read as follows:</P>
          </SECTION>
        </PART>
        <PART>
          <HD SOURCE="HED">PART 302-17—TAXES ON RELOCATION EXPENSES</HD>
          <CONTENTS>
            <SECHD>Sec.</SECHD>
            <SECTNO>302-17.0</SECTNO>
            <SUBJECT>How are the terms “I” and “you” used in this part?</SUBJECT>
            <SUBPART>
              <HD SOURCE="HED">Subpart A—General</HD>
              <SECTNO>302-17.1</SECTNO>
              <SUBJECT>What special terms apply to this part?</SUBJECT>
              <SECTNO>302-17.2</SECTNO>
              <SUBJECT>Why does relocation affect personal income taxes?</SUBJECT>
              <SECTNO>302-17.3</SECTNO>
              <SUBJECT>What is the Government's objective in reimbursing the additional income taxes incurred as a result of a relocation?</SUBJECT>
              <SECTNO>302-17.4</SECTNO>
              <SUBJECT>Why is the reimbursement for substantially all, and not exactly all, of the additional income taxes incurred as a result of a relocation?</SUBJECT>
              <SECTNO>302-17.5</SECTNO>
              <SUBJECT>Who is eligible for the withholding tax allowance and the relocation income tax allowance?</SUBJECT>
              <SECTNO>302-17.6</SECTNO>

              <SUBJECT>Who is not eligible for the WTA and the RITA?<PRTPAGE P="32344"/>
              </SUBJECT>
              <SECTNO>302-17.7</SECTNO>
              <SUBJECT>Is there any circumstance under which the WTA and the RITA are not paid even though I would otherwise be eligible?</SUBJECT>
              <SECTNO>302-17.8</SECTNO>
              <SUBJECT>What limitations and Federal income tax treatments apply to various relocation reimbursements?</SUBJECT>
              <SECTNO>302-17.9</SECTNO>
              <SUBJECT>Who is responsible for knowing which relocation expenses are taxable and which expenses are nontaxable?</SUBJECT>
              <SECTNO>302-17.10</SECTNO>
              <SUBJECT>Which expenses should I report on my state tax returns if I am required to file returns in two different states?</SUBJECT>
              <SECTNO>302-17.11</SECTNO>
              <SUBJECT>When is an expense considered completed in a specific tax year?</SUBJECT>
              <SECTNO>302-17.12</SECTNO>
              <SUBJECT>Where can I find additional information and guidance on WTA and RITA?</SUBJECT>
              <SECTNO>302-17.13</SECTNO>
              <SUBJECT>How are taxes on extended TDY benefits and taxes on relocation allowances related?</SUBJECT>
            </SUBPART>
            <SUBPART>
              <HD SOURCE="HED">Subpart B—The Withholding Tax Allowance (WTA)</HD>
              <SECTNO>302-17.20</SECTNO>
              <SUBJECT>What is the purpose of the WTA?</SUBJECT>
              <SECTNO>302-17.21</SECTNO>
              <SUBJECT>What relocation expenses does the WTA cover?</SUBJECT>
              <SECTNO>302-17.22</SECTNO>
              <SUBJECT>What relocation expenses does the WTA not cover?</SUBJECT>
              <SECTNO>302-17.23</SECTNO>
              <SUBJECT>What are the procedures for my WTA?</SUBJECT>
              <SECTNO>302-17.24</SECTNO>
              <SUBJECT>How does my agency compute my WTA?</SUBJECT>
            </SUBPART>
            <SUBPART>
              <HD SOURCE="HED">Subpart C—The Relocation Income Tax Allowance (RITA)</HD>
              <SECTNO>302-17.30</SECTNO>
              <SUBJECT>What is the purpose of the RITA?</SUBJECT>
              <SECTNO>302-17.31</SECTNO>
              <SUBJECT>What are the procedures for calculation and payment of my RITA?</SUBJECT>
              <SECTNO>302-17.32</SECTNO>
              <SUBJECT>Who chooses the one-year or two-year process?</SUBJECT>
              <SECTNO>302-17.33</SECTNO>
              <SUBJECT>May I ask my agency to recalculate my RITA?</SUBJECT>
            </SUBPART>
            <SUBPART>
              <HD SOURCE="HED">Subpart D—The Combined Marginal Tax Rate (CMTR)</HD>
              <SECTNO>302-17.40</SECTNO>
              <SUBJECT>How does my agency calculate my CMTR?</SUBJECT>
              <SECTNO>302-17.41</SECTNO>
              <SUBJECT>Is there any difference in the procedures for calculating the CMTR, depending on whether my agency chooses the one-year or two-year RITA process?</SUBJECT>
              <SECTNO>302-17.42</SECTNO>
              <SUBJECT>Which state marginal tax rate(s) does my agency use to calculate the CMTR if I incur tax liability in more than one state, and how does this affect my RITA and my state tax return(s)?</SUBJECT>
              <SECTNO>302-17.43</SECTNO>
              <SUBJECT>What local marginal tax rate(s) does my agency use?</SUBJECT>
              <SECTNO>302-17.44</SECTNO>
              <SUBJECT>What if I incur income tax liability to the Commonwealth of Puerto Rico?</SUBJECT>
              <SECTNO>302-17.45</SECTNO>
              <SUBJECT>What if I incur income tax liability to the Commonwealth of the Northern Mariana Islands or any other territory or possession of the United States?</SUBJECT>
            </SUBPART>
            <SUBPART>
              <HD SOURCE="HED">Subpart E—Special Procedure if a State Treats an Expense as Taxable Even Though It Is Nontaxable Under the Federal IRC</HD>
              <SECTNO>302-17.46</SECTNO>
              <SUBJECT>What does my agency do if a state treats an expense as taxable even though it is nontaxable under the Federal IRC?</SUBJECT>
            </SUBPART>
            <SUBPART>
              <HD SOURCE="HED">Subpart F—The One-Year RITA Process</HD>
              <SECTNO>302-17.50</SECTNO>
              <SUBJECT>What information should I provide to my agency to make the RITA calculation possible under the one-year process?</SUBJECT>
              <SECTNO>302-17.51</SECTNO>
              <SUBJECT>When should I file my “Statement of Income and Tax Filing Status” under the one-year process?</SUBJECT>
              <SECTNO>302-17.52</SECTNO>
              <SUBJECT>When should I file an amended “Statement of Income and Tax Filing Status” under the one-year process?</SUBJECT>
              <SECTNO>302-17.53</SECTNO>
              <SUBJECT>What happens if I do not file and amend the “Statement of Income and Tax Filing Status” in a timely manner?</SUBJECT>
              <SECTNO>302-17.54</SECTNO>
              <SUBJECT>How does my agency calculate my RITA under the one-year process?</SUBJECT>
              <SECTNO>302-17.55</SECTNO>
              <SUBJECT>What does my agency do once it has calculated my RITA under the one-year process?</SUBJECT>
              <SECTNO>302-17.56</SECTNO>
              <SUBJECT>What do I do, under the one-year process, once my agency has provided my W-2(s)?</SUBJECT>
            </SUBPART>
            <SUBPART>
              <HD SOURCE="HED">Subpart G—The Two-Year RITA Process</HD>
              <SECTNO>302-17.60</SECTNO>
              <SUBJECT>How are the terms “Year 1” and “Year 2” used in the two-year RITA process?</SUBJECT>
              <SECTNO>302-17.61</SECTNO>
              <SUBJECT>Is the WTA optional under the two-year process?</SUBJECT>
              <SECTNO>302-17.62</SECTNO>
              <SUBJECT>What information do I put on my tax returns for Year 1 under the two-year process?</SUBJECT>
              <SECTNO>302-17.63</SECTNO>
              <SUBJECT>What information should I provide to my agency to make the RITA calculation possible under the two-year process?</SUBJECT>
              <SECTNO>302-17.64</SECTNO>
              <SUBJECT>When should I file my “Statement of Income and Tax Filing Status” under the two-year process?</SUBJECT>
              <SECTNO>302-17.65</SECTNO>
              <SUBJECT>What happens if I do not file the “Statement of Income and Tax Filing Status” in a timely manner?</SUBJECT>
              <SECTNO>302-17.66</SECTNO>
              <SUBJECT>How do I claim my RITA under the two-year process?</SUBJECT>
              <SECTNO>302-17.67</SECTNO>
              <SUBJECT>How does my agency calculate my RITA under the two-year process?</SUBJECT>
              <SECTNO>302-17.68</SECTNO>
              <SUBJECT>What does my agency do once it has calculated my RITA under the two-year process?</SUBJECT>
              <SECTNO>302-17.69</SECTNO>
              <SUBJECT>How do I pay taxes on my RITA under the two-year process?</SUBJECT>
            </SUBPART>
            <SUBPART>
              <HD SOURCE="HED">Subpart H—Agency Responsibilities</HD>
              <SECTNO>302-17.100</SECTNO>
              <SUBJECT>May we use a relocation company to comply with the requirements of this part?</SUBJECT>
              <SECTNO>302-17.101</SECTNO>
              <SUBJECT>What are our responsibilities with regard to taxes on relocation expenses?</SUBJECT>
              <SECTNO>302-17.102</SECTNO>
              <SUBJECT>What happens if an employee fails to file and/or amend a “Statement of Income and Tax Filing Status” prior to the required date?</SUBJECT>
              <SECTNO>302-17.103</SECTNO>
              <SUBJECT>What are the advantages of choosing a one-year or a two-year RITA process?</SUBJECT>
            </SUBPART>
          </CONTENTS>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>5 U.S.C. 5724b; 5 U.S.C. 5738; E.O. 11609, as amended.</P>
          </AUTH>
          <SECTION>
            <SECTNO>§ 302-17.0</SECTNO>
            <SUBJECT>How are the terms “I” and “you” used in this part?</SUBJECT>
            <P>The pronouns “I” and “you” and their variants throughout this part refer to the employee.</P>
          </SECTION>
          <SUBPART>
            <HD SOURCE="HED">Subpart A—General</HD>
            <SECTION>
              <SECTNO>§ 302-17.1</SECTNO>
              <SUBJECT>What special terms apply to this part?</SUBJECT>
              <P>The following definitions apply to this part:</P>
              <P>Allowance:</P>
              <P>(1) Money paid to the employee to cover future expenses, such as the miscellaneous expense allowance (see part 302-16 of this chapter for information about the miscellaneous expense allowance);</P>
              <P>(2) Money paid to the employee to cover past expenses, such as the relocation income tax allowance (RITA) under the two-year tax process described in part 302-17, subpart G; or</P>
              <P>(3) A limit established by statute or regulation, such as the 18,000 pound net weight allowance for household goods shipments (see part 302-7 of this chapter for information about the 18,000 pound net weight allowance).</P>
              <P>
                <E T="03">City</E>means any unit of general local government as defined in 31 CFR 215.2(b).</P>
              <P>
                <E T="03">Combined marginal tax rate (CMTR)</E>means a single rate determined by combining the applicable marginal tax rates for Federal, state, and local income taxes, using the formula provided in § 302-17.40. If you incur liability for income tax in the Commonwealth of Puerto Rico, see § 302-17.44.</P>
              <P>
                <E T="03">County</E>means any unit of local general government as defined in 31 CFR 215.2(e).</P>
              <P>
                <E T="03">Gross-up</E>used as a noun, has two related meanings in this part. It is either:</P>
              <P>(1) The process that your agency uses to estimate the additional income tax liability that you incur as a result of relocation benefits and taxes on those benefits; or</P>
              <P>(2) The result of the gross-up process.</P>
              <P>Note to the definition of<E T="03">gross-up:</E>The gross-up allows for the fact that every reimbursement of taxes is itself taxable. Therefore, the gross-up calculates the amount an agency must reimburse an employee to cover substantially all of the income taxes incurred as the result of a relocation.</P>
              <P>
                <E T="03">Internal Revenue Code (IRC)</E>means Title 26 of the United States Code, which governs Federal income taxes.</P>
              <P>
                <E T="03">Local income tax</E>means a tax imposed by a recognized city or county tax authority that is deductible for Federal income tax purposes as a<E T="03">local income tax</E>under the IRC, at 26 U.S.C. 164(a)(3). (See the definitions for the terms<E T="03">city</E>and<E T="03">county</E>in this section.)</P>
              <P>
                <E T="03">Marginal tax rate (MTR)</E>means the tax rate that applies to the last increment of taxable income after taxable relocation benefits have been added to the employee's income. For example, a<PRTPAGE P="32345"/>married employee who files jointly has a taxable income of $120,000. According to the IRS 2010 Tax Rate Schedules, taxable income between $68,000 and $137,700 is taxed at the 25 percent tax rate; therefore, the $120,000 taxable income of the employee and spouse is in this range, so they have a 25 percent marginal tax rate. If the employee receives $30,000 of taxable relocation benefits, the taxable income for the employee and spouse is now $150,000, which is in the next highest tax bracket. In this example, the employee and spouse now have a Federal marginal tax rate of 28 percent once the taxable relocation benefits have been added to their income.</P>
              <P>
                <E T="03">Reimbursement</E>means money paid to you to cover expenses that you have already paid for out of your own funds.</P>
              <P>
                <E T="03">Relocation benefits</E>means all reimbursements and allowances that you receive, plus all direct payments that your agency makes on your behalf, in connection with your relocation.</P>
              <P>
                <E T="03">Relocation income tax allowance (RITA)</E>means the payment to the employee to cover the difference between the withholding tax allowance (WTA), if any, and the actual tax liability incurred by the employee as a result of their taxable relocation benefits; RITA is paid whenever the actual tax liability exceeds the WTA.</P>
              <P>
                <E T="03">State</E>means any one of the several states of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, or any other territory and possession of the United States.</P>
              <P>
                <E T="03">State income tax</E>means a tax imposed by a state tax authority that is deductible for Federal income tax purposes under the IRC, specifically 26 U.S.C. 164(a)(3).</P>
              <P>
                <E T="03">Withholding tax allowance (WTA)</E>means the amount paid to the Federal IRS by the agency as withholding of income taxes for any taxable relocation allowance, reimbursement, or direct payment to a vendor.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.2</SECTNO>
              <SUBJECT>Why does relocation affect personal income taxes?</SUBJECT>
              <P>When you are relocated from one permanent duty station to another, you are reimbursed by your employing agency for certain expenses. The IRC requires that you report many of these relocation benefits, including some that your agency pays on your behalf, as taxable income. When you receive taxable benefits, you must pay income tax on the amount or value of those benefits. However, 5 U.S.C. 5724b also requires that your agency reimburse you for substantially all of the additional Federal, state, and local income taxes you incur as a result of any taxable relocation benefits. A reimbursement for taxes is also a taxable benefit on which you must pay additional taxes.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.3</SECTNO>
              <SUBJECT>What is the Government's objective in reimbursing the additional income taxes incurred as a result of a relocation?</SUBJECT>
              <P>The Government's objective is to reimburse transferred employees for substantially all (not exactly all—see § 302-17.4) of the additional Federal, state, and local income taxes incurred as a result of a relocation, including the taxes on the taxable relocation benefits and the taxes on the reimbursement for taxes.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.4</SECTNO>
              <SUBJECT>Why is the reimbursement for substantially all, and not exactly all, of the additional income taxes incurred as a result of a relocation?</SUBJECT>
              <P>Because of the complexity of the calculations, which involve not only Federal income tax but also the income tax rates of many states and localities, it is not reasonable for the Government to compute the exact impact of relocation on an affected employee's taxes. Making a good faith effort to reimburse substantially all additional income taxes is sufficient. The statute where this appears, at 5 U.S.C. 5724b does not define substantially all. This part provides the description through its provisions.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.5</SECTNO>
              <SUBJECT>Who is eligible for the withholding tax allowance and the relocation income tax allowance?</SUBJECT>
              <P>(a) The withholding tax allowance (WTA) and the relocation income tax allowance (RITA) are the two allowances through which the Government reimburses you for substantially all of the income taxes that you incur as a result of your relocation. You are eligible for the WTA and the RITA if your agency is transferring you from one permanent duty station to another, in the interest of the Government, and your agency's reimbursements to you for relocation expenses result in you being liable for additional taxes.</P>
              <P>(b) If your agency chooses to offer you the choice, the WTA is optional to you. See 302-17.61 through 302-17.69.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.6</SECTNO>
              <SUBJECT>Who is not eligible for the WTA and the RITA?</SUBJECT>
              <P>You are not eligible for the WTA or the RITA if you are:</P>
              <P>(a) A new appointee;</P>
              <P>(b) Assigned under the Government Employees Training Act; or</P>
              <P>(c) Returning from an overseas assignment for the purpose of separation from Government service.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.7</SECTNO>
              <SUBJECT>Is there any circumstance under which the WTA and the RITA are not paid even though I would otherwise be eligible?</SUBJECT>
              <P>If you violate the 12-month service agreement under which you are relocated, your agency will not pay the WTA or the RITA to you, and you must repay any relocation benefits paid prior to the violation.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.8</SECTNO>
              <SUBJECT>What limitations and Federal income tax treatments apply to various relocation reimbursements?</SUBJECT>
              <P>(a) If you were moving yourself for a new job, with no help from your employer, then you probably would be able to deduct some of your relocation expenses. However, if you are eligible for WTA and RITA under this part, your Federal agency reimburses you or pays directly for many relocation expenses that otherwise would be deductible. Since you could have deducted these expenses if you had paid them yourself, the benefits you receive from your agency for these “deductible” relocation expenses are nontaxable. Therefore, you do not report them as income and you cannot take them as deductions.</P>
              <P>(b) However, many other relocation benefits are taxable income to you, the employee, because you could not have deducted them. You also may not deduct the additional taxes you incur, as a result of taxable benefits (except that you may deduct state and local income taxes on your Federal tax return). Your agency will reimburse you for most of these taxable expenses and for substantially all of the additional taxes that you incur as a result of the taxable benefits.</P>

              <P>(c) The table to § 302-17.8 summarizes the FTR allowances, limitations, and tax treatment of each reimbursement, allowance, or direct payment to a vendor. See IRS Publication 521, Moving Expenses, and the cited FTR paragraphs for details.<PRTPAGE P="32346"/>
              </P>
              <GPOTABLE CDEF="s50,r50,r25,r50" COLS="4" OPTS="L2,i1">
                <TTITLE>Table to § 302-17.8—FTR Allowances and Federal Income Tax Treatments</TTITLE>
                <BOXHD>
                  <CHED H="1">Entitlement</CHED>
                  <CHED H="1">Summary of FTR allowance</CHED>
                  <CHED H="1">FTR part or section</CHED>
                  <CHED H="1">Tax treatments</CHED>
                </BOXHD>
                <ROW>
                  <ENT I="01">Meals while en route to the new duty station</ENT>
                  <ENT>The standard CONUS per diem for meals and incidental expenses</ENT>
                  <ENT>§ 302-4.200</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Lodging while en route to the new duty station</ENT>
                  <ENT>The standard CONUS per diem for lodging expenses for the employee only</ENT>
                  <ENT>§ 302-4.200</ENT>
                  <ENT>Nontaxable provided the cost is reasonable according to the IRC.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Transportation using your POV to your new duty station</ENT>
                  <ENT>Actual cost or the rate established by the IRS for using a POV for relocation</ENT>
                  <ENT>Part 302-4</ENT>
                  <ENT>Nontaxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Transportation to your new duty station using a common carrier (an airline, for example)</ENT>
                  <ENT>Actual cost</ENT>
                  <ENT>Part 302-4</ENT>
                  <ENT>Nontaxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Per diem and transportation for househunting trip</ENT>
                  <ENT O="xl">Actual Expense Method: 10 days of per diem plus transportation expenses—must be itemized;</ENT>
                  <ENT>Part 302-5</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="22"/>
                  <ENT O="xl">
                    <E T="03">or</E>
                  </ENT>
                </ROW>
                <ROW>
                  <ENT I="22"/>
                  <ENT>Lump Sum Method: locality rate times 5 (one person) or times 6.25 (employee and spouse) for up to 10 days—no itemization required</ENT>
                  <ENT>Part 302-5</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Temporary quarters subsistence expenses (TQSE)</ENT>
                  <ENT O="xl">Actual Expense Method: Maximum of 120 days; full per diem for only the first 30 days—itemization required;</ENT>
                  <ENT>§ 302-6.100</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="22"/>
                  <ENT O="xl">
                    <E T="03">or</E>
                  </ENT>
                </ROW>
                <ROW>
                  <ENT I="22"/>
                  <ENT>Lump Sum Method: multiply number of days allowed by .75 times the locality rate (30 days maximum)—no itemization required</ENT>
                  <ENT>§ 302-6.200</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="22"/>
                  <ENT>
                    <E T="0714">Note:</E>
                    <E T="03">Additional TQSE allowances for family members are less than the benefit for the employee occupying TQ alone</E>
                  </ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Shipment of household goods (HHG)</ENT>
                  <ENT>Transportation of up to 18,000 pounds</ENT>
                  <ENT>§ 302-7.2</ENT>
                  <ENT>Transportation of goods from your former residence to your new residence is nontaxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Temporary storage of household goods in transit, as long as the expenses are incurred within any 30 calendar day period after the day your items are removed from your old residence and before they are delivered to the new residence</ENT>
                  <ENT>Temporary storage of up to 30 days (However, see the section immediately below)</ENT>
                  <ENT>§ 302-7.8</ENT>
                  <ENT>Nontaxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Temporary storage of household goods beyond 30 days</ENT>
                  <ENT>Temporary storage of 60 plus 90 days, NTE 150 days</ENT>
                  <ENT>§ 302-7.8</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Extended storage of Household Goods (HHG)</ENT>
                  <ENT>CONUS—TCS (per agency policy) or isolated duty station only</ENT>
                  <ENT>Part 302-8, Subpart B</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="22"/>
                  <ENT>OCONUS—Agency policy</ENT>
                  <ENT>Part 302-8, Subparts C and D</ENT>
                  <ENT>Nontaxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Transportation of privately-owned vehicle (POV)</ENT>
                  <ENT>CONUS—Agency discretion</ENT>
                  <ENT>Part 302-9, Subpart D</ENT>
                  <ENT>Nontaxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="22"/>
                  <ENT>OCONUS—Agency discretion</ENT>
                  <ENT>Part 302-9, Subparts B &amp; C</ENT>
                  <ENT>Nontaxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Shipment of mobile home in lieu of HHG</ENT>
                  <ENT>Limited to maximum allowance for HHG</ENT>
                  <ENT>§ 302-10.3</ENT>
                  <ENT>Nontaxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="22">Residence transactions:</ENT>
                </ROW>
                <ROW>
                  <ENT I="03">• Sale of home</ENT>
                  <ENT>Closing costs up to 10% of actual sales price</ENT>
                  <ENT>§ 302-11.300(a)</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="03">• Purchase of home</ENT>
                  <ENT>Closing costs up to 5% of actual purchase price</ENT>
                  <ENT>§ 302-11.300(b)</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="03">• Lease-breaking</ENT>
                  <ENT>Itemization required</ENT>
                  <ENT>§§ 302-11.430 &amp; 431</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Payments to Relocation Service Contractors</ENT>
                  <ENT>According to agency policy and contracts</ENT>
                  <ENT>Part 302-12</ENT>
                  <ENT>Taxability determined on a case-by-case basis.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Home Marketing Incentive Payment</ENT>
                  <ENT>See internal agency policies and regulations</ENT>
                  <ENT>Part 302-14</ENT>
                  <ENT>Taxable, but not eligible for WTA or RITA.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Property Management Services</ENT>
                  <ENT>See internal agency policies and regulations</ENT>
                  <ENT>Part 302-15</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Miscellaneous expenses</ENT>
                  <ENT>$500 or $1,000; or</ENT>
                  <ENT>§ 302-16.102</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="22"/>
                  <ENT>Maximum of 1 or 2 weeks basic pay</ENT>
                  <ENT>§ 302-16.103</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Withholding tax allowance</ENT>
                  <ENT>25 percent of reimbursements, allowances, and direct payments to vendors</ENT>
                  <ENT>Part 302-17, Subpart B</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
                <ROW>
                  <PRTPAGE P="32347"/>
                  <ENT I="01">Relocation income tax allowance</ENT>
                  <ENT>Based on income and tax filing status.</ENT>
                  <ENT>Part 302-17, Subpart C</ENT>
                  <ENT>Taxable.</ENT>
                </ROW>
              </GPOTABLE>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.9</SECTNO>
              <SUBJECT>Who is responsible for knowing which relocation expenses are taxable and which expenses are nontaxable?</SUBJECT>
              <P>Both you and your agency must know which reimbursements and direct payments to vendors are taxable and which are nontaxable in your specific circumstances. When you submit a voucher for reimbursement, your agency must determine whether the reimbursement is taxable income at the Federal, state, and/or local level. Then, when you file your income tax returns, you must report the taxable allowances, reimbursements, and direct payments to vendors as income. Your agency is ultimately responsible for calculating and reporting withholding accurately, and you are ultimately responsible for filing your taxes correctly.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.10</SECTNO>
              <SUBJECT>Which expenses should I report on my state tax returns if I am required to file returns in two different states?</SUBJECT>
              <P>In most cases, your state tax return for the state you are leaving should reflect your reimbursement or allowance, if any, for househunting expenses and your reimbursement or direct payments to vendors for real estate expenses at the home you are leaving. All other taxable expenses should be shown as income on the tax return you file in the state into which you have moved. However, you and your agency must carefully study the rules in both states and include everything that each state considers to be income on each of your state tax returns.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.11</SECTNO>
              <SUBJECT>When is an expense considered completed in a specific tax year?</SUBJECT>
              <P>A reimbursement, allowance, or direct payment to a vendor is considered completed in a specific tax year only if the money was actually disbursed to the employee or vendor during the tax year in question.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.12</SECTNO>
              <SUBJECT>Where can I find additional information and guidance on WTA and RITA?</SUBJECT>
              <P>To find additional information and guidance on WTA and RITA, see:</P>
              <P>(a) IRS Publication 521, Moving Expenses; and</P>

              <P>(b) FTR Bulletins; GSA publishes additional information on RITA, including the illustrations and examples of various RITA computations, in FTR Bulletins which are updated as necessary. The current GSA FTR Bulletins may be found at<E T="03">http://www.gsa.gov/bulletins.</E>
              </P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.13</SECTNO>
              <SUBJECT>How are taxes on extended TDY benefits and taxes on relocation allowances related?</SUBJECT>
              <P>(a) Taxes on extended TDY benefits are computed using exactly the same processes described in this part for the WTA and RITA except that:</P>
              <P>(1) The tax process for extended TDY benefits uses the term “withholding tax allowance ” (WTA) in exactly the same fashion as the process for taxes on relocation allowances; however, in place of the term “relocation income tax allowance,” the tax process for extended TDY benefits uses the term “extended TDY tax reimbursement allowance” (ETTRA); and</P>
              <P>(2) All benefits are taxable under extended TDY, so the sections of this part that discuss which benefits are taxable and which are not have no relevance to ETTRA.</P>
              <P>(b) See part 301-11, subpart F of this title for additional information about taxes on extended TDY benefits.</P>
            </SECTION>
          </SUBPART>
          <SUBPART>
            <HD SOURCE="HED">Subpart B—The Withholding Tax Allowance (WTA)</HD>
            <SECTION>
              <SECTNO>§ 302-17.20</SECTNO>
              <SUBJECT>What is the purpose of the WTA?</SUBJECT>
              <P>(a) The purpose of the WTA is to protect you from having to use part of your relocation expense reimbursements to pay Federal income tax withholding; it does not cover state taxes, local taxes, Medicare taxes, or Social Security taxes (see § 302-17.22(c) and (d)).</P>
              <P>(b) If your agency chooses to offer you the choice, the WTA is optional to you. See 302-17.61 through 302-17.69.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.21</SECTNO>
              <SUBJECT>What relocation expenses does the WTA cover?</SUBJECT>
              <P>The WTA covers certain allowances, reimbursements, and/or direct payments to vendors, to the extent that each of them is taxable income. It does not cover any allowance, reimbursement, or direct payment to a vendor that is nontaxable; that is, your agency will not give you a WTA for anything that is not considered taxable income to you (see the table in § 302-17.8 for a summary of tax treatment). In particular, the WTA covers:</P>
              <P>(a) En route meals and incidental expenses—Reimbursements for meals and incidental expenses while en route are taxable and, therefore, are covered by the WTA.</P>
              <P>(b) Househunting trip—Travel (including per diem and transportation) expenses for you (and your spouse) for one round trip to the new official station to seek permanent residence quarters. Househunting is covered regardless of whether it is reimbursed under the actual expense or lump sum method. (See part 302-5 of this chapter.)</P>
              <P>(c) Temporary quarters—Subsistence expenses for you and your immediate family during occupancy of temporary quarters. Temporary quarters are covered regardless of whether it is reimbursed under the actual expense or lump sum method. (See part 302-6 of this chapter.)</P>
              <P>(d) Extended storage expenses—Extended storage for a temporary change of station in CONUS or assignment to an isolated duty station in CONUS, but only if these expenses are allowed by part 302-8 of this chapter and your agency's policy.</P>
              <P>(e) Real estate expenses—Expenses for the sale of the residence at your old official station and purchase of a home at your new official station. This can also include expenses for settling an unexpired lease (“breaking” a lease) at your old official station. (See part 302-11 of this chapter. If you do not hold full title to the home you are selling or buying, see § 302-12.7 of this chapter.)</P>
              <P>(f) Expenses paid by a relocation company to the extent such payments constitute taxable income to the employee. The extent to which such payments constitute taxable income varies according to the individual circumstances of your relocation, and by the state and locality in which you reside. (See IRS Publication 521, Moving Expenses, and appropriate state and local tax authorities for additional information.)</P>
              <P>(g) Property Management Services—Payment for the services of a property manager for renting rather than selling a residence at your old official station. (See part 302-15 of this chapter.)</P>
              <P>(h) Miscellaneous expense allowance—Miscellaneous expenses for defraying certain relocation expenses not covered by other relocation benefits. (See part 302-16 of this chapter.)</P>
            </SECTION>
            <SECTION>
              <PRTPAGE P="32348"/>
              <SECTNO>§ 302-17.22</SECTNO>
              <SUBJECT>What relocation expenses does the WTA not cover?</SUBJECT>
              <P>The WTA does not cover the following relocation expenses:</P>
              <P>(a) Any reimbursement, allowance, or direct payment to a vendor that should not be reported as taxable income when you file your Federal tax return; this includes but is not limited to en route lodging and transportation, HHG transportation, and transportation of POVs.</P>
              <P>(b) Reimbursed expenses for extended storage of household goods during an OCONUS assignment, if reimbursement is permitted under your agency's policy.</P>
              <P>(c) State and local withholding tax obligations. To the extent that your state or local tax authority requires periodic (such as quarterly) tax payments, you are responsible to pay these from your own funds. Your agency reimburses you for substantially all of these payments through the RITA process, but your agency does not provide a WTA for them. If required to by state or local law, your agency may withhold these from your reimbursement.</P>
              <P>(d) Additional taxes due under the Federal Insurance Contributions Act including Social Security tax, if applicable, and Medicare tax. Current law does not allow Federal agencies to reimburse transferees for these employment taxes on relocation benefits. However, your agency will deduct for these taxes from your reimbursements for taxable items.</P>
              <P>(e) Any reimbursement amount that exceeds the actual expense paid or incurred. For example, if your reimbursement for the movement of household goods is based on the commuted rate schedule but your actual relocation expenses are less than that, your tax liability for the difference is not covered by the WTA or RITA.</P>
              <P>(f) Home marketing incentive payment. In accordance with FTR part 302-14, your agency may not provide you either a WTA or RITA for this incentive.</P>
              <P>(g) Any recruitment, relocation, or retention incentive payment that you receive. Any withholding of taxes for such payments is outside the scope of this regulation. Rather, it is covered by regulations issued by the Office of Personnel Management, Treasury's Financial Management Service, and the IRS.</P>
              <P>(h) Any allowances, reimbursements, and/or direct payments to vendors not related to your relocation; for example, a reimbursement for office supplies would not be covered by the WTA, even if it occurred during your relocation.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.23</SECTNO>
              <SUBJECT>What are the procedures for my WTA?</SUBJECT>
              <P>(a) Your agency prepares a relocation travel authorization, which includes an estimate of the WTA and RITA, to obligate funds for your relocation.</P>
              <P>(b) Your agency pays certain allowances to you. Your agency also pays vendors directly for other relocation expenses.</P>
              <P>(c) Your agency instructs you as to whether to submit one voucher after you have completed your relocation or to submit vouchers at various points as your relocation progresses plus another when your relocation is completed.</P>
              <P>(d) You submit your voucher(s) for reimbursement of certain relocation expenses.</P>
              <P>(e) Your agency determines the extent to which each allowance, each item on your voucher(s), and each direct payment to a vendor is nontaxable or is taxable income to you under the IRC.</P>
              <P>(f) For the taxable items, your agency calculates your WTA and any reimbursement(s) due to you in accordance with § 302-17.24. Your agency sets aside the amount of your WTA and pays the IRS as a withholding tax in accordance with IRS requirements.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.24</SECTNO>
              <SUBJECT>How does my agency compute my WTA?</SUBJECT>
              <P>(a) Your agency computes your WTA by applying the grossed-up withholding formula below each time your agency incurs a covered, taxable relocation expense, regardless of whether it is a reimbursement, allowance, or direct payment to a vendor.</P>
              <P>(b) The law currently provides for a withholding rate of 25 percent for “supplemental wages” that are identified separately from regular wages (This rate has not always been 25 percent and may change in the future; GSA will revise the FTR to reflect any changes as quickly as possible, but users of this part should see IRS Publication 15, Employer's Tax Guide, for the most current rate). Taxable payments for relocation expenses are “supplemental wages,” as defined in IRS Publication 15. However, you owe taxes on the WTA itself because, like most other relocation allowances, it is taxable income. To reimburse you for the taxes on the WTA itself, your agency computes the WTA by multiplying the reimbursement, allowance, or direct payment to a vendor by 0.3333 instead of 0.25. That is:</P>
              
              <FP SOURCE="FP-2">WTA = R/(1-R) × Expense</FP>
              <FP SOURCE="FP-2">Where R is the withholding rate for supplemental wages, or</FP>
              <FP SOURCE="FP-2">WTA = 0.25/(1 −0.25) × Expense, or 0.3333 × Expense</FP>
              <GPOTABLE CDEF="s50,12" COLS="2" OPTS="L2,p1,8/9,i1">
                <TTITLE>Example 1—Calculating the Withholding Tax Allowance (WTA)</TTITLE>
                <BOXHD>
                  <CHED H="1"/>
                  <CHED H="1"/>
                  <CHED H="1"/>
                </BOXHD>
                <ROW>
                  <ENT I="01">Househunting Trip Actual Expense Claim</ENT>
                  <ENT>3,000</ENT>
                </ROW>
                <ROW>
                  <ENT I="02" O="xl">WTA = .3333 × $3,000 = $999.90</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Temporary Quarters Lump Sum Allowance</ENT>
                  <ENT>5,000</ENT>
                </ROW>
                <ROW>
                  <ENT I="02" O="xl">WTA = .3333 × $5,000 = $1,666.50</ENT>
                </ROW>
                <ROW>
                  <ENT I="03" O="xl">Total WTA $999.90 + $1,666.50 = $2,666.40</ENT>
                </ROW>
              </GPOTABLE>
              <NOTE>
                <HD SOURCE="HED">Note:</HD>
                <P>Your agency must deduct withholding for Medicare and FICA (Social Security) from your reimbursement for expenses such as househunting, as the WTA does not cover such expenses.</P>
              </NOTE>
            </SECTION>
          </SUBPART>
          <SUBPART>
            <HD SOURCE="HED">Subpart C—The Relocation Income Tax Allowance (RITA)</HD>
            <SECTION>
              <SECTNO>§ 302-17.30</SECTNO>
              <SUBJECT>What is the purpose of the RITA?</SUBJECT>

              <P>(a) The purpose of the RITA is to reimburse you for any taxes that you owe that were not adequately reimbursed by the WTA. As discussed in § 302-17.24, the WTA calculation is based on the 25 percent income tax withholding rate applicable to supplemental wages. This may be higher or lower than your actual tax rate. The RITA, on the other hand, is based on your marginal tax rate, determined by your actual taxable income and filing status, which allows your agency to reimburse you for<E T="03">substantially all</E>of your Federal income taxes. The RITA also reimburses you for any additional state and local taxes that you incur as a result of your relocation, because they are not reimbursed in the WTA process.</P>
              <P>(b) The WTA may be optional to you. See 302-17.61 for a discussion of criteria for choosing whether or not to accept the WTA. See 302-17.62 through 302-17.69 for procedures if you choose not to accept the WTA.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.31</SECTNO>
              <SUBJECT>What are the procedures for calculation and payment of my RITA?</SUBJECT>
              <P>The procedures for the calculation and payment of your RITA depend on whether your agency has chosen to use a one-year or two-year RITA process. See subpart F for the one-year process and subpart G for the two-year process.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.32</SECTNO>
              <SUBJECT>Who chooses the one-year or two-year process?</SUBJECT>

              <P>Your agency or a major component of your agency determines whether it will adopt a one-year or two-year RITA process. Your agency may use the one-year RITA process for one or more specific categories of employees and the<PRTPAGE P="32349"/>two-year process for one or more other categories.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.33</SECTNO>
              <SUBJECT>May I ask my agency to recalculate my RITA?</SUBJECT>
              <P>(a) Yes, you may ask your agency to recalculate your RITA provided you filed your “Statement of Income and Tax Filing Status,” and amended it, if necessary, in a timely manner. If, once you have completed all Federal, state, and local tax returns, you believe that your RITA should have been significantly different from the RITA that your agency calculated, you may ask your agency to recalculate your RITA. This is true for either the one-year or two-year process. With any request for recalculation, you must submit a statement explaining why you believe your RITA was incorrect.</P>
              <P>(b) Please note that your agency may require that you also submit an amended “Statement of Income and Tax Filing Status” (if, for example, you inadvertently did not report some of your income in your original Statement), your actual tax returns, or both, as attachments to your request for recalculation.</P>
              <NOTE>
                <HD SOURCE="HED">Note to § 302-17.33:</HD>
                <P>Please see § 302-17.55, if your agency uses a one-year RITA process, or § 302-17.69, if your agency uses a two-year RITA process, for more information about positive and negative RITA calculations.</P>
              </NOTE>
            </SECTION>
          </SUBPART>
          <SUBPART>
            <HD SOURCE="HED">Subpart D—The Combined Marginal Tax Rate (CMTR)</HD>
            <SECTION>
              <SECTNO>§ 302-17.40</SECTNO>
              <SUBJECT>How does my agency calculate my CMTR?</SUBJECT>
              <P>(a) The CMTR is a key element that greatly enhances the accuracy of the calculation of your RITA. Your agency uses the information on your “Statement of Income and Tax Filing Status,” as amended, to determine your CMTR, as follows (see subparts F and G of this part for information about the “Statement of Income and Tax Filing Status”).</P>
              <P>(b) The CMTR is, in essence, a combination of your Federal, state, and local tax rates. However, the CMTR cannot be calculated by merely adding the Federal, state, and local marginal tax rates together because of the deductibility of state and local income taxes from income on your Federal income tax return. The formula prescribed below for calculating the CMTR, therefore, is designed to adjust the state and local tax rates to compensate for their deductibility from income for Federal tax purposes.</P>
              <P>(c) The formula for calculating the CMTR is:</P>
              
              <FP SOURCE="FP-2">CMTR = F + (1−F)S + (1−F)L</FP>
              
              <EXTRACT>
                <FP SOURCE="FP-2">Where:</FP>
                
                <FP SOURCE="FP-2">F = Your Federal marginal tax rate</FP>
                <FP SOURCE="FP-2">S = Your state marginal tax rate, if any</FP>
                <FP SOURCE="FP-2">L = Your local marginal tax rate, if any</FP>
              </EXTRACT>
              
              <P>(d) Your agency finds the Federal marginal tax rate by comparing your taxable income, as shown in your “Statement of Income and Filing Status,” to the Federal tax tables in the current year's Form 1040-ES instructions (See §§ 302-17.50 through 302-17.53 and §§ 302-17.63 through 302-17.65 for additional information on the “Statement of Income and Tax Filing Status.”)</P>
              <P>(e) Your agency finds the state and local marginal tax rates that apply to you (if any) by comparing your taxable income to the most current state and/or local tax tables provided by the states and localities. Every Federal payroll office and every provider of tax calculation software has these tables readily available, and the tables are also available on the Web sites of the various state and local taxing authorities.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.41</SECTNO>
              <SUBJECT>Is there any difference in the procedures for calculating the CMTR, depending on whether my agency chooses the one-year or two-year RITA process?</SUBJECT>
              <P>No. The procedures for calculating the CMTR are the same for the one-year and two-year RITA processes.</P>
              <GPOTABLE CDEF="s50,12" COLS="2" OPTS="L2,i1">
                <TTITLE>Example 2—Calculating the Combined Marginal Tax Rate</TTITLE>
                <BOXHD>
                  <CHED H="1"/>
                  <CHED H="1">Percent</CHED>
                </BOXHD>
                <ROW>
                  <ENT I="01">Federal marginal tax rate</ENT>
                  <ENT>33</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">State marginal tax rate</ENT>
                  <ENT>6</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Local marginal tax rate</ENT>
                  <ENT>3</ENT>
                </ROW>
              </GPOTABLE>
              <FP SOURCE="FP-2">
                <E T="03">CMTR</E>= 0.33 + (1.00−0.33)(.06) + (1.00−0.33)(0.03) = .3903 or 39.03%</FP>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.42</SECTNO>
              <SUBJECT>Which state marginal tax rate(s) does my agency use to calculate the CMTR if I incur tax liability in more than one state, and how does this affect my RITA and my state tax return(s)?</SUBJECT>
              <P>If two or more states that are involved in your relocation impose an income tax on relocation benefits, then your relocation benefits may be taxed by both states. Most commonly, your old and new duty stations are in the two states involved. The following table lays out the possibilities:</P>
              <GPOTABLE CDEF="s50,r50,r50,r50,r50" COLS="5" OPTS="L2,tp0,i1">
                <TTITLE/>
                <BOXHD>
                  <CHED H="1">If:</CHED>
                  <CHED H="1">But:</CHED>
                  <CHED H="1">Your agency will use the following as the state marginal tax rate in the CMTR:</CHED>
                  <CHED H="1">Your RITA will include an appropriate allowance for:</CHED>
                  <CHED H="1">Your action:</CHED>
                </BOXHD>
                <ROW>
                  <ENT I="01">Only one involved state has a state income tax</ENT>
                  <ENT/>
                  <ENT>The marginal tax rate of the one state that taxes income</ENT>
                  <ENT>Taxes you incur in that state</ENT>
                  <ENT>You pay the taxes required by the state that taxes income.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Each involved state taxes a different set of your relocation benefits, with no overlap</ENT>
                  <ENT/>
                  <ENT>The average of the marginal tax rates for each state involved</ENT>
                  <ENT>Taxes you incur in all involved states</ENT>
                  <ENT>You file tax returns in each involved state and pay the applicable taxes.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Two or more involved states tax some of your same relocation benefits</ENT>
                  <ENT>All involved states<E T="03">allow</E>you to adjust or take a credit for income taxes paid to other states</ENT>
                  <ENT>The marginal tax rate of the state that has the highest state income tax rate</ENT>
                  <ENT>Taxes you incur in all involved states</ENT>
                  <ENT>You file tax returns in each involved state, take the appropriate credits and/or adjustments, and pay the applicable taxes.</ENT>
                </ROW>
                <ROW>
                  <ENT I="01">Two or more involved states tax some of the same relocation benefits</ENT>
                  <ENT>One or more involved states<E T="03">does not allow</E>you to adjust or take a credit for income taxes paid to other states</ENT>
                  <ENT>The sum of all applicable state marginal tax rates</ENT>
                  <ENT>Taxes you incur in all involved states</ENT>
                  <ENT>You file tax returns in each involved state, and pay the applicable taxes. This may result in paying taxes in more than one state on the same relocation benefits.</ENT>
                </ROW>
              </GPOTABLE>
            </SECTION>
            <SECTION>
              <PRTPAGE P="32350"/>
              <SECTNO>§ 302-17.43</SECTNO>
              <SUBJECT>What local marginal tax rate(s) does my agency use?</SUBJECT>
              <P>(a) If you incur local tax liability, you provide the applicable marginal tax rate(s) on your “Statement of Income and Tax Filing Status. Your agency validates the applicable local marginal tax rate(s) and uses it (them) in the CMTR formula.</P>
              <P>(b) If you incur local income tax liability in more than one locality, then your agency should follow the rules described for state income taxes in § 302-17.42 to calculate the local marginal tax rate that will be used in the CMTR formula and to compute your RITA, and you should follow the rules in § 302-17.42 to determine your actions.</P>
              <P>(c) If a locality in which you incur income tax liability publishes its tax rates in terms of a percentage of your Federal or state taxes, then your agency must convert that tax rate to a percentage of your income to use it in computing your CMTR. This is accomplished by multiplying the applicable Federal or state tax rate by the applicable local tax rate. For example, if the state marginal tax rate is 6 percent and the local tax rate is 50 percent of state income tax liability, the local marginal tax rate stated as a percentage of taxable income would be 3 percent.</P>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.44</SECTNO>
              <SUBJECT>What if I incur income tax liability to the Commonwealth of Puerto Rico?</SUBJECT>
              <P>A Federal employee who is relocated to or from a point, or between points, in the Commonwealth of Puerto Rico may be subject to income tax by both the Federal government and the government of Puerto Rico. However, under current Puerto Rico law, an employee receives a credit on his/her Puerto Rico income tax for the amount of taxes paid to the Federal government. Therefore:</P>

              <P>(a) If the applicable Puerto Rico marginal tax rate, as shown in the tables provided by the Commonwealth of Puerto Rico, is<E T="03">equal to or lower</E>than the applicable Federal marginal tax rate, then your agency uses the Federal marginal tax rates and the formula in § 302-17.40(c) in calculating your CMTR.</P>

              <P>(b) If the applicable Puerto Rico marginal tax rate, as shown in the tables provided by the Commonwealth of Puerto Rico, is<E T="03">higher</E>than the applicable Federal marginal tax rate, and if all of the states involved either have no income tax or allow an adjustment or credit for income taxes paid to the other state(s) and Puerto Rico, then your agency uses the rate for Puerto Rico in place of the Federal marginal tax rate in the formula in § 302-17.40(c).</P>

              <P>(c) If the applicable Puerto Rico marginal tax rate, as shown in the tables provided by the Commonwealth of Puerto Rico, is<E T="03">higher</E>than the applicable Federal marginal tax rate and one or more of the state(s) involved does not allow an adjustment or credit for income taxes paid to the other state(s) and/or Puerto Rico, then your agency uses the formula below:</P>
              
              <FP SOURCE="FP-2">CMTR = P + S + L</FP>
              
              <EXTRACT>
                <FP SOURCE="FP-2">Where:</FP>
                
                <FP SOURCE="FP-2">P = Your Puerto Rico marginal tax rate</FP>
                <FP SOURCE="FP-2">S = Your state marginal tax rate, if any</FP>
                <FP SOURCE="FP-2">L = Your local marginal tax rate, if any</FP>
              </EXTRACT>
            </SECTION>
            <SECTION>
              <SECTNO>§ 302-17.45</SECTNO>
              <SUBJECT>What if I incur income tax liability to the Commonwealth of the Northern Mariana Islands or any other territory or possession of the United States?</SUBJECT>
              <P>If you are relocated to, from, or within the Commonwealth of the Northern Mariana Islands or any territory or possession of the United States that is not covered by the definitions in § 302-17.7 or § 302-17.44, your agency will have to determine the tax rules of that locality and then include those taxes in your RITA calculation, as applicable.</P>
            </SECTION>
          </SUBPART>
          <SUBPART>
            <HD SOURCE="HED">Subpart E—Special Procedure if a State Treats an Expense as Taxable Even Though It Is Nontaxable Under the Federal IRC</HD>
            <SECTION>
              <SECTNO>§ 302-17.46</SECTNO>
              <SUBJECT>What does my agency do if a state treats an expense as taxable even though it is nontaxable under the Federal IRC?</SUBJECT>
              <P>(a) If one or more of the states where you have incurred tax liability for relocation expenses treats one or more relocation expenses as taxable, even though it (they) are nontaxable under Federal tax rules, you may be required to pay additional state income tax when you file tax returns with those states. In this case, your agency calculates a state gross-up to cover the additional tax liability resulting from the covered relocation expense reimbursement(s) that are nontaxable under Federal, but not state tax rules. Your agency calculates the state gross-up and then adds that amount to your RITA. Your agency will use this formula to calculate the state gross-up:</P>
              
              <GPH DEEP="29" SPAN="1">
                <GID>EP06JN11.056</GID>
              </GPH>
              <EXTRACT>
                <FP SOURCE="FP-2">F = Federal Marginal Tax Rate</FP>
                
                <FP SOURCE="FP-2">S = State Marginal Tax Rate</FP>
                <FP SOURCE="FP-2">C = CMTR</FP>
                <FP SOURCE="FP-2">N = Dollar amount of covered relocation expenses that are nontaxable under Federal tax rules but are taxable under state tax rules</FP>
              </EXTRACT>
              
              <P>All information, except “N,” can be found in previous calculations (if moving to, from, or within Puerto Rico, follow the rules in 302-17.44 to determine when to substitute “P” for “F”).</P>
              <P>“N” is determined as follows:</P>
              <P>1. Take the dollar amount of reimbursements, allowances, and direct payments to vendors treated as nontaxable under Federal tax rules.</P>
              <P>2. Subtract the dollar amount of reimbursements, allowances, and direct payments to vendors treated as nontaxable by the state.</P>
              <P>3. The difference represents “N.”</P>
              <P>(b) This calculation is the same, regardless of whether your agency has chosen to use the one-year or two-year RITA process.</P>
            </SECTION>
          </SUBPART>
          <SUBPART>
            <HD SOURCE="HED">Subpart F—The One-Year RITA Process</HD>
            <SECTION>
              <SECTNO>§ 302-17.50</SECTNO>
              <SUBJECT>What information should I provide to my agency to make the RITA calculation possible under the one-year process?</SUBJECT>
              <P>You should provide the information required in the following “Statement of Income and Tax Filing Status.”</P>
              <HD SOURCE="HD1">Statement of Income and Tax Filing Status—One-Year Process</HD>
              <P>The following information, which my agency will use in calculating the RITA to which I am entitled, was shown on the Federal, state, and local income tax returns that I (or my spouse and I) filed for the 20__ tax year (this should be the most recent year in which you filed).</P>
              <FP>Filing status:</FP>
              
              <FP SOURCE="FP-2">☐ Single☐ Head of Household</FP>
              <FP SOURCE="FP-2">☐ Married Filing Jointly</FP>
              <FP SOURCE="FP-2">☐ Qualifying Widow(er)</FP>
              <FP SOURCE="FP-2">☐ Married Filing Separately</FP>
              
              <P>(a) Taxable income as shown on my (our) IRS Form 1040: $ __</P>
              <P>Significant future changes in income (including cost of living raises) that you can foresee for the current year:</P>
              <FP>_Increase_ Decrease _</FP>
              <FP>No Foreseeable Changes</FP>
              <P>(b) Approximate net amount of this (these) change(s): $ __</P>
              <P>(c) Predicted taxable income for the current tax year 20_ =</P>
              <P>Sum of (a) and (b) = $ __</P>
              <FP SOURCE="FP-2">State you are moving out of :___</FP>
              <P>Marginal Tax Rate: __%</P>
              <FP SOURCE="FP-2">State you are moving into: ___</FP>
              <P>Marginal Tax Rate: __%</P>
              <FP SOURCE="FP-2">Locality you are moving out of: ___</FP>
              <P>Marginal Tax Rate: __%</P>
              <FP SOURCE="FP-2">Locality you are moving into: ___</FP>
              <P>Marginal Tax Rate: __%</P>
              
              <PRTPAGE P="32351"/>
              <P>The above information is true and accurate to the best of my (our) knowledge. I (we) agree to notify the appropriate agency official of any significant changes to the above so that appropriate adjustments to the RITA can be made.</P>
              
            </SECTION>
          </SUBPART>
        </PART>
        <FP SOURCE="FP-DASH"/>
        <FP SOURCE="FP-2">Employee's signature</FP>
        <FP SOURCE="FP-DASH"/>
        <FP SOURCE="FP-2">Date</FP>
        
        <FP SOURCE="FP-DASH"/>
        <FP>Spouse's signature</FP>
        <FP SOURCE="FP-DASH"/>
        <FP>Date (if filing jointly)</FP>
        <SECTION>
          <SECTNO>§ 302-17.51</SECTNO>
          <SUBJECT>When should I file my “Statement of Income and Tax Filing Status” under the one-year process?</SUBJECT>
          <P>For the one-year process, you should file this form as soon as you receive your relocation orders, or as soon as you file your tax returns for the most recent tax year, whichever occurs later.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.52</SECTNO>
          <SUBJECT>When should I file an amended “Statement of Income and Tax Filing Status” under the one-year process?</SUBJECT>
          <P>You should submit an amended “Statement of Income and Tax Filing Status” to your agency under the one-year process whenever the information on it changes, and you should continue to amend it until you have received the last W-2 from your agency in connection with a specific relocation. In particular, you should file an amended version of this statement whenever:</P>
          <P>(a) Your filing status changes;</P>
          <P>(b) Your income changes enough that your income, including WTA and RITA, might put you into a different tax bracket; or</P>
          <P>(c) You have taxable relocation expenses in a second or third year.</P>
          <NOTE>
            <HD SOURCE="HED">Note to § 302-17.52:</HD>
            <P>Your agency will not be able to use your original or amended “Statement of Income and Tax Filing Status” if you file it after the cut-off date established by your agency in accordance with § 302-17.54(b).</P>
          </NOTE>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.53</SECTNO>
          <SUBJECT>What happens if I do not file and amend the “Statement of Income and Tax Filing Status” in a timely manner?</SUBJECT>
          <P>If you don't file the “Statement of Income and Tax Filing Status” and/or amend it when necessary, your agency will switch to the 2-year process, and because the WTA is an advance of your income tax expenses, you will be liable to repay the full amount of the WTA that your agency has paid to the IRS. See subpart G of this part.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.54</SECTNO>
          <SUBJECT>How does my agency calculate my RITA under the one-year process?</SUBJECT>
          <P>(a) Your agency provides allowances to you, reimburses you for vouchers that you submit, and pays certain relocation vendors directly, all during the calendar year as described in subpart B of this part. Some of these reimbursements, allowances, and direct payments to vendors are taxable income to you, the employee, as described in subpart A of this part. Your agency computes a WTA and reports the WTA to the IRS as taxes withheld for you for each of these taxable reimbursements, allowances, and direct payments to vendors.</P>
          <NOTE>
            <HD SOURCE="HED">Note to § 302-17.54(a):</HD>
            <P>The WTA may be optional to you. However, if your agency is using a one-year RITA process, there is no advantage to you in choosing not to receive the WTA, because your agency will adjust the WTA payment to the IRS. See 302-17.55(a)(1).</P>
          </NOTE>
          <P>(b) Your agency establishes a cutoff date (for example, December 1), after which it will not issue reimbursements or allowances to you or make direct payments to relocation vendors for the rest of the calendar year.</P>
          <P>(c) If the information on your “Statement of Income and Tax Filing Status” changes after you have submitted the initial version, you must submit an amended “Statement of Income and Tax Filing Status” no later than your agency's cutoff date.</P>
          <P>(d) During the period between the cutoff date and the end of the calendar year, your agency calculates your RITA.</P>
          <P>(e) Your RITA is itself taxable income to you. To account for taxes on the RITA, your agency will gross-up your RITA by using a gross-up formula that multiplies the grossed-up CMTR by the total of all covered taxable relocation benefits, and then subtracts your grossed-up WTA from that total. That is:</P>
          <GPH DEEP="29" SPAN="1">
            <GID>EP06JN11.398</GID>
          </GPH>
          <EXTRACT>
            <FP SOURCE="FP-2">Where</FP>
            
            <FP SOURCE="FP-2">C = CMTR</FP>
            <FP SOURCE="FP-2">R = Reimbursements, allowances, and direct payments to vendors covered by WTA</FP>
            <FP SOURCE="FP-2">Y = Total grossed-up WTAs paid during the current year.</FP>
          </EXTRACT>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.55</SECTNO>
          <SUBJECT>What does my agency do once it has calculated my RITA under the one-year process?</SUBJECT>
          <P>(a) Your RITA is likely to be different from the sum of the WTA computed and reported during the year, because the WTA is calculated using a flat rate, established by the IRC, while the RITA is calculated using the CMTR. Therefore:</P>
          <P>(1) If the calculation above results in a negative value (that is, if your agency's calculation shows that it withheld and reported too much money as WTA), then your agency will send an adjustment to the IRS using Form 941. In this case, your agency does not make a RITA payment to you because you do not need additional funds to pay your taxes. That is, everything you need to pay substantially all of your taxes was included in the adjusted WTA, and that is the amount that will appear on your Form W-2.</P>
          <P>(2) If the calculation above results in a positive value (that is if your agency's calculation shows that it did not withhold enough money for your income taxes), then your agency will pay your RITA to you before the end of the calendar year and report it to the IRS as part of your income for that year.</P>
          <P>(b) Shortly after the end of the calendar year, your agency will provide one or two W-2 Forms to you. At your agency's discretion, you may receive one W-2 that includes all of your taxable relocation expenses, WTA, and RITA (if any), along with your payroll wages, or you may receive one W-2 for your payroll wages and a separate one for your taxable relocation expenses, WTA, and RITA.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.56</SECTNO>
          <SUBJECT>What do I do, under the one-year process, once my agency has provided my W-2(s)?</SUBJECT>
          <P>(a) You must use all W-2(s) that you have received to file your tax returns. On those returns, you must include all taxable relocation expenses shown on your W-2(s) as income, including your WTA and RITA (if any). Please note that you must also include all WTA as withholding, in addition to the standard withholding from your payroll wages.</P>
          <P>(b) If you finished your relocation within one calendar year, and your agency paid all of your relocation reimbursements, allowances, and direct payments to vendors in the same calendar year, before the cutoff date, then your tax returns for that calendar year are the end of your relocation tax process. If, on the other hand, your agency reimburses you for relocation expenses, or pays allowances or relocation vendors on your behalf, during a second (and possibly a third) calendar year, then you and your agency repeat the process above for each of those years.</P>
        </SECTION>
        <SUBPART>
          <HD SOURCE="HED">Subpart G—The Two-Year RITA Process</HD>
          <SECTION>
            <SECTNO>§ 302-17.60</SECTNO>
            <SUBJECT>How are the terms “Year 1” and “Year 2” used in the two-year RITA process?</SUBJECT>

            <P>(a) Year 1 is the calendar year in which the agency reimburses you for a specific expense, provides an allowance, or pays a vendor directly. If your reimbursements, allowances, and/or direct payments to vendors occur in<PRTPAGE P="32352"/>more than one calendar year, you will have more than one Year 1.</P>
            <P>(b) Year 2 is the calendar year in which you submit your RITA claim and your agency pays your RITA to you.</P>
            <P>(c) In most cases:</P>
            <P>(1) For every Year 1 you will have a corresponding Year 2;</P>
            <P>(2) Every Year 2 immediately follows a Year 1; and</P>
            <P>(3) Year 2 is the year in which you file a tax return reflecting your remaining tax liability for taxable reimbursement(s), allowance(s), and/or direct payments to vendors in each Year 1.</P>
            <P>(d) The table below offers a graphic explanation of Year 1 and Year 2, assuming that you begin your relocation in 2010 and incurred additional approved expenses in 2011 and 2012.</P>
            <GPOTABLE CDEF="s50,r50,r50,r50" COLS="4" OPTS="L2,tp0,i1">
              <TTITLE/>
              <BOXHD>
                <CHED H="1">2010</CHED>
                <CHED H="1">2011</CHED>
                <CHED H="1">2012</CHED>
                <CHED H="1">2013</CHED>
              </BOXHD>
              <ROW>
                <ENT I="01">First Year 1</ENT>
                <ENT>Second Year 1<E T="03">and</E>Year 2 for 2010</ENT>
                <ENT>Third Year 1<E T="03">and</E>Year 2 for 2011</ENT>
                <ENT>Year 2 for 2012.</ENT>
              </ROW>
            </GPOTABLE>
          </SECTION>
          <SECTION>
            <SECTNO>§ 302-17.61</SECTNO>
            <SUBJECT>Is the WTA optional under the two-year process?</SUBJECT>
            <P>(a) Yes. If your agency makes the WTA optional to you, you may choose to not receive the WTA.</P>
            <P>(b) WTA is paid at a rate of 25 percent. When deciding whether or not to receive the WTA, you should consider the following:</P>
            <P>(1) If you expect that your marginal Federal tax rate will be 25 percent or higher for the calendar year for which you received the majority of your relocation reimbursements, you may want to elect to receive the WTA, because your initial reimbursements will be higher, as shown in the following Example 3).</P>
            <GPOTABLE CDEF="xls40,9,r100" COLS="3" OPTS="L1,p1,8/9,i1">
              <TTITLE>Example 3—Claims Paid With and Without WTA</TTITLE>
              <BOXHD>
                <CHED H="1"/>
                <CHED H="1"/>
                <CHED H="1"/>
              </BOXHD>
              <ROW EXPSTB="02">
                <ENT I="22">Allowance computed without WTA:</ENT>
              </ROW>
              <ROW EXPSTB="00">
                <ENT I="22"/>
                <ENT>$1,000.00</ENT>
                <ENT>Miscellaneous Expenses Allowance.</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Minus</ENT>
                <ENT>250.00</ENT>
                <ENT>Federal Withholding Tax (25%).</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Minus</ENT>
                <ENT>14.50</ENT>
                <ENT>Medicare Withholding Tax (1.45%).</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Minus</ENT>
                <ENT>62.50</ENT>
                <ENT>FICA (Social Security) Tax (6.20%).</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Equals</ENT>
                <ENT>673.50</ENT>
                <ENT>Amount due to the transferee.</ENT>
              </ROW>
              <ROW EXPSTB="02">
                <ENT I="22">Allowance computed with WTA:</ENT>
              </ROW>
              <ROW EXPSTB="00">
                <ENT I="22"/>
                <ENT>$1,000.00</ENT>
                <ENT>Miscellaneous Expenses Allowance.</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Plus</ENT>
                <ENT>333.30</ENT>
                <ENT>Withholding Tax Allowance (25% of $1333.30).</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Equals</ENT>
                <ENT>1,333.30</ENT>
                <ENT>Net allowance with WTA.</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Minus</ENT>
                <ENT>333.30</ENT>
                <ENT>Federal Withholding Tax (25%).</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Minus</ENT>
                <ENT>19.33</ENT>
                <ENT>Medicare Withholding Tax (1.45%).</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Minus</ENT>
                <ENT>82.66</ENT>
                <ENT>FICA (Social Security) Tax (6.20%).</ENT>
              </ROW>
              <ROW>
                <ENT I="03">Equals</ENT>
                <ENT>898.01</ENT>
                <ENT>Amount due to the transferee.</ENT>
              </ROW>
            </GPOTABLE>
            <P>(2) If you expect that your marginal Federal tax rate will be less than 25 percent, you may want to decline the WTA to avoid or limit possible overpayment of the WTA, the so-called “negative RITA” situation (In a “negative RITA” situation, you must repay some of the WTA in Year 2). However, even if your marginal Federal tax rate will be less than 25 percent, you may want to accept the WTA so that your initial reimbursement is larger. Example 3 shows the relative reimbursements you would receive by accepting and declining the WTA, in the case of a hypothetical $1000 Miscellaneous Expense Allowance.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 302-17.62</SECTNO>
            <SUBJECT>What information do I put on my tax returns for Year 1 under the two-year process?</SUBJECT>
            <P>(a) Your agency provides allowances to you, reimburses you for vouchers that you submit, and pays certain relocation vendors directly, all during the same calendar year, as described in subpart B of this part. Some of these reimbursements, allowances, and direct payments to vendors are taxable income to you, the employee. Your agency computes a WTA and reports that withholding to the IRS for each of these that is taxable. This is Year 1 of the two-year process.</P>
            <P>(b) If your agency makes the WTA optional to you and you have chosen not to receive the WTA, then your agency computes withholding tax for each taxable reimbursement, allowance, and direct payment, and reports that withholding to the IRS. See Example 3 in this section</P>
            <P>(c) Shortly after the end of the calendar year, your agency provides one or more W-2 forms to you. At its discretion, your agency may include all of your taxable relocation expenses and WTA (if any) in one W-2, along with your regular payroll wages, or it may provide you one W-2 for your regular payroll wages and a separate W-2 for your taxable relocation expenses and WTA (if any).</P>
            <P>(d) At approximately the same time as your agency provides your W-2(s), it also may provide you an itemized list of all relocation benefits and the WTA (if any) for each benefit. You should use this statement to verify that your agency has included all covered taxable items in its calculations and to check your agency's calculations.</P>
            <P>(e) You must submit all W-2s that you have received with your Year 1 tax returns. On those returns, you must include all taxable relocation expenses during the previous year as income. Furthermore, you must include the WTA (if any) as tax payments that your agency made for you during the previous year, in addition to the regular withholding of payroll taxes from your salary.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 302-17.63</SECTNO>
            <SUBJECT>What information should I provide to my agency to make the RITA calculation possible under the two-year process?</SUBJECT>
            <P>You should provide the information required in the following “Statement of Income and Tax Filing Status.” This information should be taken from the income tax returns you filed for Year 1.</P>
            <HD SOURCE="HD1">Statement of Income and Tax Filing Status—Two-Year Process</HD>

            <P>The following information, which my agency will use in calculating the RITA<PRTPAGE P="32353"/>to which I am entitled, was shown on the Federal, state and local income tax returns that I (or my spouse and I) filed for the 20_______ tax year.</P>
            <FP>Filing status:</FP>
            
            <FP SOURCE="FP-2">□Single□ Head of Household</FP>
            <FP SOURCE="FP-2">□ Married Filing Jointly</FP>
            <FP SOURCE="FP-2">□ Qualifying Widow(er)</FP>
            <FP SOURCE="FP-2">□ Married Filing Separately</FP>
            <P>Taxable income as shown on my (our) IRS Form 1040: $ _____________</P>
            <FP>State you are moving out of:_________________</FP>
            <P>Marginal Tax Rate: _______%</P>
            <FP>State you are moving into: _________________</FP>
            <P>Marginal Tax Rate: _______%</P>
            <FP>Locality you are moving out of: _______________</FP>
            <P>Marginal Tax Rate: ________%</P>
            <FP>Locality you are moving into: _______________</FP>
            <P>Marginal Tax Rate: ________%</P>
            
            <P>The above information is true and accurate to the best of my (our) knowledge. I (we) agree to notify the appropriate agency official of any significant changes to the above so that appropriate adjustments to the RITA can be made.</P>
          </SECTION>
        </SUBPART>
        <FP SOURCE="FP-DASH"/>
        <FP>Employee's signature</FP>
        <FP SOURCE="FP-DASH"/>
        <FP>Date</FP>
        <FP SOURCE="FP-DASH"/>
        <FP>Spouse's signature (if filing jointly)</FP>
        <FP SOURCE="FP-DASH"/>
        <FP>Date</FP>
        <SECTION>
          <SECTNO>§ 302-17.64</SECTNO>
          <SUBJECT>When should I file my “Statement of Income and Tax Filing Status” and RITA claim under the two-year process?</SUBJECT>
          <P>For the two-year process, you should file the “Statement of Income and Tax Filing Status” in Year 2, along with your RITA claim, after you file your income tax return. If your agency pays any taxable expenses covered by the WTA (if any) in more than one year, then you will have to file a new “Statement of Income and Tax Filing Status” each year. Your agency establishes the deadline each year for filing of your Statement.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.65</SECTNO>
          <SUBJECT>What happens if I do not file the “Statement of Income and Tax Filing Status” in a timely manner?</SUBJECT>
          <P>The WTA is an advance on your income tax expenses, thus if you don't file the “Statement of Income and Tax Filing Status” in a timely manner, your agency will require you to repay the entire amount of the withholding and WTA (if any) that the agency has paid on your behalf.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.66</SECTNO>
          <SUBJECT>How do I claim my RITA under the two-year process?</SUBJECT>
          <P>(a) To claim your RITA under the two-year process, you must submit a voucher and attach the “Statement of Income and Tax Filing Status,” as discussed in §§ 302-17.63—302-17.65.</P>
          <P>(b) Your voucher must claim a specific amount. However, your agency will calculate your actual RITA after you submit your RITA voucher and your “Statement of Income and Tax Filing Status;” the amount you claim on your voucher does not enter into that calculation. You should perform the RITA calculation for yourself, as a check on your agency's calculation, but you are not required to put the “right answer” on the voucher you submit to claim your RITA.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.67</SECTNO>
          <SUBJECT>How does my agency calculate my RITA under the two-year process?</SUBJECT>
          <P>(a) Your agency calculates your RITA after receipt of your RITA voucher.</P>
          <P>(b) Your RITA is itself taxable income to you. To account for taxes on the RITA, your agency will gross-up your RITA by applying the CMTR to the final amount rather than the reimbursed amount.</P>
          <P>(c) Thus, your agency calculates your RITA by multiplying the Combined Marginal Tax Rate (CMTR) (using the state and local tax tables most current at the time of the RITA calculation) by the total of all covered taxable relocation benefits during the applicable Year 1, and then subtracting your WTA(s), if any, from the same Year 1 from that total. That is:</P>
          <GPH DEEP="43" SPAN="1">
            <GID>EP06JN11.399</GID>
          </GPH>
          <EXTRACT>
            <FP SOURCE="FP-2">Where C = CMTR</FP>
            <FP SOURCE="FP-2">R = Reimbursements, allowances, and direct payments to vendors covered by WTA during Year 1</FP>
            <FP SOURCE="FP-2">Z = Total grossed-up WTAs paid during Year 1.</FP>
          </EXTRACT>
          <NOTE>
            <HD SOURCE="HED">Note to 302-17.67(c):</HD>
            <P>If your agency chooses to offer you the choice, the WTA is optional to you. If the employee has declined the WTA, enter zero for element Z in the above calculation.</P>
          </NOTE>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.68</SECTNO>
          <SUBJECT>What does my agency do once it has calculated my RITA under the two-year process?</SUBJECT>
          <P>(a) Your RITA is likely to be different from the sum of the WTA(s) paid during Year 1, if any, because the WTA is calculated using a flat rate, established by the IRC, while the RITA is calculated using the CMTR. Therefore:</P>
          <P>(1) If the RITA calculation in § 302-17.67 results in a negative value (that is, if your agency's calculation shows that it withheld and reported too much money as income taxes), then your agency will report this result to you and will send you a bill for the difference, to repay the excess amount that it sent to the IRS on your behalf as withheld income taxes. The IRS will credit you for the full amount of withheld taxes, including the excess amount, when you file your income tax return for Year 1; therefore, you must repay the excess amount to your agency within 90 days, or within a time period set by your agency. If you are required to repay an amount in Year 2 that was included as wages on your W-2 in Year 1, you may be entitled to a miscellaneous itemized deduction on your Federal income tax return in Year 2. For more information, see IRS Publication 535, “Business Expenses.” If your agency chooses to offer you the choice, then you may want to decline the WTA to avoid this so-called “negative RITA” situation.</P>
          <P>(2) If the RITA calculation in § 302-17.67 results in a positive value (that is, if your agency's calculation shows that it did not withhold enough money as income taxes), then your agency will pay your RITA to you before the end of Year 2 and will report it to the IRS as part of your income for that year. Also, after your agency has paid your RITA to you, it will provide a W-2 that shows your RITA as taxable income to you.</P>
          <P>(b) At your agency's discretion, you may receive one W-2 that includes all of your taxable relocation expenses, WTA (if any), and RITA (if any), along with your regular payroll wages, or you may receive one W-2 for your regular payroll wages and a separate one for your taxable relocation expenses, WTA, and RITA.</P>
        </SECTION>
        <SECTION>
          <SECTNO>§ 302-17.69</SECTNO>
          <SUBJECT>How do I pay taxes on my RITA under the two-year process?</SUBJECT>
          <P>When income taxes are due for Year 2, you must report your RITA, if any, as taxable income on your Federal, state, and local tax returns.</P>
          <P>(a) If your relocation process results in only one Year 2, or if the previous year was your last Year 1, your RITA is the only amount that you report as income resulting from your relocation for that Year 2.</P>

          <P>(b) If, on the other hand, your relocation process results in more than one Year 2 (if, for example, you incurred relocation expenses during more than one calendar year), then, except for your last Year 2, you will need to report reimbursements, allowances, direct payments to vendors, and WTA(s), if any, for succeeding Year 1's at the same time that you report each Year 2's RITA.<PRTPAGE P="32354"/>
          </P>
          <P>(c) See the table in § 302-17.60 for a graphic explanation of Year 1 and Year 2.</P>
        </SECTION>
        <SUBPART>
          <HD SOURCE="HED">Subpart H—Agency Responsibilities</HD>
          <SECTION>
            <SECTNO>§ 302-17.100</SECTNO>
            <SUBJECT>May we use a relocation services provider to comply with the requirements of this part?</SUBJECT>
            <P>Yes. You may use the services of relocation companies to manage all aspects of relocation, including the RITA computation. Agencies that relocate few employees or do not have the resources to manage the complexity of relocation may find that the use of relocation companies is a practical alternative. As another alternative, agencies with infrequent requirements for relocation or with inadequate internal resources may establish an interagency agreement with one or more other agencies to pool resources to provide this service.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 302-17.101</SECTNO>
            <SUBJECT>What are our responsibilities with regard to taxes on relocation expenses?</SUBJECT>
            <P>To ensure that all provisions of this part are fulfilled, you must:</P>
            <P>(a) Prepare a relocation travel authorization that includes an estimate of the WTA and RITA, to obligate the funds that will be needed.</P>
            <P>(b) Determine, in light of the specific circumstances of each employee relocation, which reimbursements, allowances, and direct payments to vendors are taxable, and which are nontaxable.</P>
            <P>(c) Decide whether or not you will allow individual employees and/or categories of employees to choose not to receive the WTA.</P>
            <P>(d) Calculate the WTA, and credit the amount of the WTA to the employee at the time of reimbursement.</P>
            <P>(e) Prepare the employee's W-2 Form(s) and ensure that it (they) reflect(s) the WTA.</P>
            <P>(f) Provide each employee an itemized list of relocation expenses after the end of each calendar year in which you provided an allowance, reimbursement, or direct payment to a vendor.</P>
            <P>(g) Establish processes for identifying the relevant Federal, state, and local marginal tax rates and for keeping that information current.</P>
            <P>(h) Establish processes for identifying states that treat a reimbursement or direct payment to a vendor as taxable even though it is nontaxable under the Federal IRC, and for keeping that information current.</P>
            <P>(i) Calculate the employee's CMTR(s).</P>
            <P>(j) Decide whether you will use the one-year or two-year RITA process and whether you will use different processes (that is, one-year or two-year) for different groups of employees within your agency.</P>
            <P>(k) Make sure the RITA calculation is done correctly and in a timely manner, whether your policies call for the calculation to be done by you or by a third party.</P>
            <P>(l) Make sure that payment of the RITA occurs in a timely manner (this is especially critical for the one-year process).</P>
            <P>(m) Develop criteria for accepting and rejecting requests for recalculation of RITA.</P>
            <P>(n) Establish a process for recalculating the RITA when the employee's request for recalculation is accepted.</P>
            <P>(o) Consult with IRS for clarification of any confusion stemming from taxes on relocation expenses.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 302-17.102</SECTNO>
            <SUBJECT>What happens if an employee fails to file and/or amend a “Statement of Income and Tax Filing Status” prior to the required date?</SUBJECT>
            <P>(a) If a relocating employee does not file and/or amend a “Statement of Income and Tax Filing Status” prior to the required date, and you are using a one-year RITA process, you are to switch to a two-year RITA process and send a written warning to the employee reminding them of the requirement and informing them that if they do not submit the “Statement of Income and Tax Filing Status,” you may declare the entire amount of the WTA forfeited.</P>
            <P>(b) If the relocating employee does not file and/or amend a Statement of Income and Tax Filing Status prior to the required date, and you are using a two-year RITA process, you are to send the employee a written warning informing them they have 60 days to file or amend their “Statement of Income and Tax Filing Status,” or you will declare the WTA that you have already paid on his/her behalf forfeited and due as a debt to the Government.</P>
            <P>(c) If the relocating employee chose not to receive the WTA and fails to file a Statement of Income and Tax Filing Status prior to your required date, you are to send the employee a written warning that they have 60 days to file. If the employee still fails to file, you may close your case file and refuse any later claims for RITA related to this specific relocation.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 302-17.103</SECTNO>
            <SUBJECT>What are the advantages of choosing a one-year or a two-year RITA process?</SUBJECT>
            <P>(a) The one-year process is simpler. It reimburses the employee more quickly, and it eases the administrative burden required to calculate the RITA. Most importantly, the one-year process eliminates the possibility of charging employees for excess payments to the IRS, the so-called “negative RITA.”</P>
            <P>(b) The two-year process provides a somewhat more accurate calculation of the additional taxes the employee incurs because it is based on the employee's actual Year One taxable income and filing status rather than the taxable income and filing status from the year before.</P>
            
          </SECTION>
        </SUBPART>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13356 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6820-14-P</BILCOD>
    </PRORULE>
  </PRORULES>
  <VOL>76</VOL>
  <NO>108</NO>
  <DATE>Monday, June 6, 2011</DATE>
  <UNITNAME>Notices</UNITNAME>
  <NOTICES>
    <NOTICE>
      <PREAMB>
        <PRTPAGE P="32355"/>
        <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
        <SUBAGY>Rural Business-Cooperative Service</SUBAGY>
        <SUBAGY>Rural Utilities Service</SUBAGY>
        <SUBJECT>Notice of Funds Availability (NOFA) Inviting Applications for the Biorefinery Assistance Program</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Rural Business-Cooperative Service and Rural Utilities Service, USDA.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of Funds Availability: Extension of Application Deadline.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>With this notice, the Agency is extending the period of time for acceptance of applications for Fiscal Year 2011 program funds available under the Biorefinery Assistance Program, which provides guaranteed loans for the development and construction of commercial-scale biorefineries or for the retrofitting of existing facilities using eligible technology for the development of advanced biofuels.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Applications must be received in the USDA Rural Development National Office no later than 4:30 pm Eastern Time on July 6, 2011 in order to compete for Fiscal Year 2011 program funds. Any application received after 4:30 pm Eastern Time on July 6, 2011, regardless of the application's postmark, will not be considered for Fiscal Year 2011 program funds.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Applications and forms may be obtained from:</P>
          <P>• U.S. Department of Agriculture, Rural Development, Energy Branch, Attention: BioRefinery Assistance Program, 1400 Independence Avenue, SW., STOP 3225, Washington, DC 20250-3225.</P>
          <P>•<E T="03">Agency Web site: http://www.rurdev.usda.gov/BCP_Biorefinery.html.</E>Follow instructions for obtaining the application and forms.</P>

          <P>Submit an original completed application with two copies to USDA's Rural Development National Office: Energy Branch,<E T="03">Attention:</E>BioRefinery Assistance Program, 1400 Independence Avenue, SW., STOP 3225, Washington, DC, 20250-3225.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Kelley Oehler, Energy Branch, Biorefinery Assistance Program, U.S. Department of Agriculture, 1400 Independence Avenue, SW., Mail Stop 3225, Washington, DC, 20250-3225.<E T="03">Telephone:</E>202-720-6819.<E T="03">E</E>-<E T="03">mail: kelley.oehler@wdc.usda.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>

        <P>On March 11, 2011, the Agency issued a Notice of Funds Availability (NOFA) for the Biorefinery Assistance program (the “Program”) in the<E T="04">Federal Register</E>(76 FR 13351) announcing the availability of approximately $129 million in mandatory budget authority to support guaranteed loans under this Program in Fiscal Year 2011, in addition to any carry-over funds from Fiscal Year 2010. This budget authority represents approximately $463 million in program funds. Further, the March 11, 2011, NOFA provided the opportunity to submit applications for the Program, with an original application deadline of May 10, 2011.</P>
        <P>The Agency has received 10 applications in response to the March 11, 2011, NOFA. These applications are the first applications received subsequent to the Biorefinery Assistance Program's interim rule published on February 14, 2011 (76 FR 8404). As there was some confusion about the information to be provided, the Agency has determined it appropriate to extend the application deadline.</P>
        <P>All other requirements for submitting applications remain the same as described in the March 11, 2011, NOFA.</P>
        <SIG>
          <DATED>Dated:<E T="03">May 31, 2011.</E>
          </DATED>
          <NAME>Cheryl L. Cook,</NAME>
          <TITLE>Acting Under Secretary, Rural Development.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13850 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 3410-XY-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">BROADCASTING BOARD OF GOVERNORS</AGENCY>
        <SUBJECT>Privacy Act of 1974: New System Of Records</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Broadcasting Board of Governors (BBG).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of a new system of records.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>BBG proposes to add a new system of records to its inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 522a), as amended. The primary purposes of the system are: (a) To ensure the safety and security of BBG facilities, systems, or information, and our occupants and uses; (b) To verify that all persons entering federal facilities, using federal information resources, or accessing classified information are authorized to do so; (c) To track and control PIV card issued to persons entering and exiting the facilities using systems, or accessing classified information. This action is necessary to meet the requirements of the Privacy Act to publish in the<E T="04">Federal Register</E>notice of the existence and character of records maintained by the agency (5 U.S.C. 522a(e)(4)).</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>This action will be effective without further notice on July 18, 2011 unless comments are received that would result in a contrary determination.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>Send written comments to the Broadcasting Board of Governors,<E T="03">Attn:</E>Paul Kollmer, Chief Privacy Officer, 330 Independence Avenue, Room 3349, Washington, DC 20237.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Michael Lawrence, 202-382-7779.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The creation of this system of records is required to implement the Homeland Security Presidential Directive 12 (HSPD-12) mandate to create a common identification standard for all Federal employees and contractors.</P>
        <SIG>
          <P>International Broadcasting Bureau.</P>
          <NAME>Richard M. Lobo,</NAME>
          <TITLE>Director.</TITLE>
        </SIG>
        <HD SOURCE="HD1">Broadcasting Board of Governors (BBG)</HD>
        <HD SOURCE="HD1">System of Records Notice (SORN) for Personal Identity Verification (PIV) System</HD>
        <PRIACT>
          <HD SOURCE="HD1">BROADCASTING BOARD OF GOVERNORS [BBG-20]</HD>
          <HD SOURCE="HD2">SYSTEM NAME:</HD>
          <P>M/SEC-Office of Security (Personal Identity Verification (PIV) System).</P>
          <HD SOURCE="HD2">SYSTEM LOCATION:</HD>

          <P>Broadcasting Board of Governors (BBG), 330 Independence Avenue, SW., Washington, DC 20237.<PRTPAGE P="32356"/>
          </P>
          <HD SOURCE="HD2">SECURITY CLASSIFICATION:</HD>
          <P>None.</P>
          <HD SOURCE="HD2">CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:</HD>

          <P>Individuals who require regular, ongoing access to BBG facilities, information technology systems, or information classified in the interest of national security, including applicants for employment or contracts, federal employees, contractors, and individuals formerly in any of these positions. The system also includes individuals accused of security violations or found in violation. The system also includes individuals authorized to perform or use services provided in agency facilities (<E T="03">e.g.,</E>Fitness Center, Cafeteria, or<E T="03">etc.</E>)</P>
          <P>The system does not apply to occasional visitors or short-term guests to whom BBG will issue temporary identification and credentials.</P>
          <HD SOURCE="HD2">CATEGORIES OF RECORDS IN THE SYSTEM:</HD>
          <P>Records maintained on individuals issued credentials by BBG include the following data fields: Full name; Social Security number; date of birth; signature; image (photograph); fingerprints; hair color; eye color; height; weight; organization/office of assignment; company name; telephone number; copy of background investigation form; PIV card issue and expiration dates; personal identification number (PIN); results of background investigation; PIV request form; PIV security sponsor approval signature; PIV card serial number; copies of documents used to verify identification or information derived from those documents such as document title, document issuing authority, document number, document expiration date, document other information); computer system user name; user access and permission rights, authentication certificates; and digital signature information.</P>
          <P>Records maintained on card holders entering BBG facilities or using BBG systems include: Name, PIV Card serial number; date, time, and location of entry and exit; company name; contain in the record but not on the PIV card and expiration date; digital signature information; computer networks/applications/data accessed.</P>
          <HD SOURCE="HD2">AUTHORITY FOR MAINTENANCE OF THE SYSTEM:</HD>
          <P>5 U.S.C. 301; Federal Information Security Act (Pub. L. 104-106, sec. 5113); Electronic Government Act (Pub. L. 104-347, sec. 203); the Paperwork Reduction Act of 1995 (44 U.S.C. 3501); and the Government Paperwork Elimination Act (Pub. L. 105-277, 44 U.S.C. 3504); Homeland Security Presidential Directive (HSPD) 12, Policy for a Common Identification Standard for Federal Employees and Contractors, August 27, 2004; Federal Property and Administrative Act of 1949, as amended.</P>
          <HD SOURCE="HD2">PURPOSE:</HD>
          <P>
            <E T="03">The primary purposes of the system are:</E>(a) To ensure the safety and security of BBG facilities, systems, or information, and our occupants and users; (b) To verify that all persons entering federal facilities, using federal information resources, or accessing classified information are authorized to do so; (c) To track and control PIV cards issued to persons entering and exiting the facilities, using systems, or accessing classified information.</P>
          <HD SOURCE="HD2">ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:</HD>
          <P>Information about covered individuals may be disclosed without consent as permitted by the Privacy Act of 1974, 5 U.S.C. 552a(b) the Statement of General Routine Uses Applicable to All BBG System of Records Files, and:</P>
          <P>•<E T="03">To a court or adjudicative body in a proceeding when:</E>(a) The agency or any component thereof; (b) any employee of the agency in his or her official capacity; (c) any employee of the agency in his or her individual capacity where agency or the Department of Justice has agreed to represent the employee; or (d) the United States Government, is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the litigation and the use of such records is therefore deemed by the agency to be for a purpose that is compatible with the purpose for which the agency collected the records.</P>
          <P>• Except as noted on Forms SF 85, 85-P, and 86, when a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto, disclosure may be made to the appropriate public authority, whether Federal, foreign, State, local, or tribal, or otherwise, responsible for enforcing, investigating or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation, or order issued pursuant thereto, if the information disclosed is relevant to any enforcement, regulatory, investigative or prosecutorial responsibility of the receiving entity.</P>
          <P>• To a Federal State, or local agency, or other appropriate entities or individuals, or through established liaison channels to selected foreign governments, in order to enable an intelligence agency to carry out its responsibilities under the National Security Act of 1947 as amended, the CIA Act of 1949 as amended, Executive Order 12333 or any successor order, applicable national security directives, or classified implementing procedures approved by the Attorney General and promulgated pursuant to such statutes, orders or directives.</P>
          <P>• To notify another federal agency when, or verify whether, a PIV card is no longer valid.</P>
          <HD SOURCE="HD2">DISCLOSURE TO CONSUMER REPORTING AGENCIES:</HD>
          <P>Privacy Act information may be reported to consumer reporting agencies pursuant to 5 U.S.C. 552a(b)(12).</P>
          <HD SOURCE="HD2">POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:</HD>
          <HD SOURCE="HD2">STORAGE:</HD>
          <P>Records are stored in electronic media or in paper files in a secured Federal facility and a lockable storage area.</P>
          <HD SOURCE="HD2">RETRIEVABILITY:</HD>
          <P>Records are retrievable by name, Social Security number, other ID number, PIV card serial number, image (photograph), and fingerprint.</P>
          <HD SOURCE="HD2">SAFEGUARDS:</HD>

          <P>Paper records are kept in a controlled area, which uses electronic high security lock that is armed with motion detector. The motion detector is connected to a guard station that is manned on a constant basis. The controlled area is equipped with locked cabinets within a Security File Room. Access to paper records is restricted to individuals whose role requires use of the records. The computer servers in which records are stored are located in facilities that are secured by alarm systems and off-master key access. The computer servers themselves are password-protected. Access by individuals working at guard stations is password-protected; each person granted access to the system at guard stations must be individually authorized to use the system. A Privacy Act Warning Notice appears on the monitor screen when records containing information on individuals are first displayed. Data exchanged between the servers and the client PCs at the guard stations and badging office is encrypted. Backup tapes are stored in a locked and controlled room in a secure, off-site location.<PRTPAGE P="32357"/>
          </P>
          <P>An audit trail is maintained and reviewed periodically to identify unauthorized access. Persons given roles in the PIV process must complete training specific to their roles to ensure they are knowledgeable about how to protect personally identifiable information.</P>
          <HD SOURCE="HD2">RETENTION AND DISPOSAL:</HD>
          <P>Pursuant to GRS 18, Item 22a records used to initiate background investigations; register and enroll individuals; manage the PIV card lifecycle; and, verify, authenticate and revoke PIV cardholder access to Federal resources are destroyed upon notification of death or not later than 5 years after separation or transfer of employee or no later than 5 years after contract relationship expires, whichever is applicable.</P>
          <P>Pursuant to GRS 11, Item PIV cards are destroyed three months after they are returned to the issuing office. Pursuant to GRS 11, Item 4a identification credentials are destroyed by cross-cut shredding no later than 90 days after deactivation.</P>
          <P>Pursuant to GRS 18, Item 17 registers or logs used to record names of outside contractors, service personnel, visitors, employees admitted to areas, and reports on automobiles and passengers for areas under maximum security are destroyed five years after final entry or five years after date of document, as appropriate.</P>
          <P>Other documents pursuant to GRS 18, Item 17b are destroyed two years after final entry or two years after date of document, as appropriate.</P>
          <HD SOURCE="HD2">SYSTEM MANAGER(S) AND ADDRESS:</HD>

          <P>Michael Lawrence, Director of Security (DAA/SAO), International Broadcasting Bureau, 330 C Street, SW., Room 4117, Washington, DC 20237, (202) 382-7779,<E T="03">mtlawren@bbg.gov.</E>
          </P>
          <HD SOURCE="HD2">NOTIFICATION PROCEDURES:</HD>

          <P>Individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the BBG FOIA Office, whose contact information can be found at<E T="03">http://www.bbg.gov/reports/foia</E>/. If an individual believes more than one component maintains Privacy Act records concerning him or her, the individual may submit the request to the Chief FOIA Officer, Broadcasting Board of Governors, 330 Independence Avenue, SW., Room 3349, Washington, DC 20237.</P>
          <P>When seeking records about yourself from this system of records or any other Agency system of records your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty or perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the BBG FOIA Office at the address above or by calling 202-203-4550.</P>
          <P>In addition to the requirements above, in your request you should:</P>
          <P>—Provide an explanation of why you believe the Agency would have information about you;</P>
          <P>—Identify which component(s) of the Agency you believe may have the information about you;</P>
          <P>—Specify when you believe the records would have been created;</P>
          <P>—Provide any other information that will help the FOIA staff determine which BBG component agency may have responsive records;</P>
          <P>—If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his/her records.</P>
          <P>Without this bulleted information the component(s) will not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.</P>
          <HD SOURCE="HD2">RECORDS ACCESS PROCEDURES:</HD>
          <P>See “Notification Procedures” above.</P>
          <HD SOURCE="HD2">CONTESTING RECORD PROCEDURES:</HD>
          <P>See “Notification Procedures” above.</P>
          <HD SOURCE="HD2">RECORD SOURCE CATEGORIES:</HD>
          <P>Employee, contractor, or applicant; sponsoring agency; former sponsoring agency; other federal agencies; contract employer; former employer.</P>
          <HD SOURCE="HD2">EXEMPTIONS CLAIMED FOR THE SYSTEM:</HD>
          <P>None.</P>
        </PRIACT>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13364 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8610-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
        <SUBAGY>International Trade Administration</SUBAGY>
        <DEPDOC>[A-570-848]</DEPDOC>
        <SUBJECT>Freshwater Crawfish Tail Meat From the People's Republic of China: Extension of Time Limit for Preliminary Results of Antidumping Duty Administrative Review</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Import Administration, International Trade Administration, Department of Commerce.</P>
        </AGY>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>June 6, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Dmitry Vladimirov, AD/CVD Operations, Office 5, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230;<E T="03">telephone:</E>(202) 482-0665.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">Background</HD>

        <P>On October 28, 2010, the Department of Commerce (the Department) initiated an administrative review of the antidumping duty order on freshwater crawfish tail meat from the People's Republic of China (PRC) for the period September 1, 2009, through August 31, 2010. See<E T="03">Initiation of Antidumping and Countervailing Duty Administrative Reviews,</E>75 FR 66349 (October 28, 2010). We initiated an administrative review of six companies. On February 28, 2011, we rescinded the review of the order with respect to Yancheng Hi-King.<E T="03">See Freshwater Crawfish Tail Meat From the People's Republic of China: Rescission of Antidumping Duty Administrative Review in Part,</E>76 FR 10879 (February 28, 2011). The preliminary results of the review are currently due no later than June 2, 2011.</P>
        <HD SOURCE="HD1">Extension of Time Limit for Preliminary Results</HD>
        <P>Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to complete the preliminary results within 245 days after the last day of the anniversary month of an order for which a review is requested and the final results within 120 days after the date on which the preliminary results are published. If it is not practicable to complete the review within these time periods, section 751(a)(3)(A) of the Act allows the Department to extend the time limit for the preliminary results to a maximum of 365 days after the last day of the anniversary month.</P>

        <P>We determine that it is not practicable to complete the preliminary results of<PRTPAGE P="32358"/>this review within the original time limit because we require additional time to analyze various recently filed submissions of factual information submitted by both parties. In addition, the numerous extensions requested by, and granted to, the interested parties for filing various responses has contributed to the Department's need for additional time to complete the preliminary results. Therefore, we are extending the time period for issuing the preliminary results of this review by 46 days until July 18, 2011.</P>
        <P>This notice is published in accordance with section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2).</P>
        <SIG>
          <DATED>Dated: May 27, 2011.</DATED>
          <NAME>Christian Marsh,</NAME>
          <TITLE>Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13909 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF DEFENSE</AGENCY>
        <SUBAGY>Office of the Secretary</SUBAGY>
        <SUBJECT>Open Meeting Notice; Advisory Council on Dependents' Education</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Department of Defense Education Activity (DoDEA), DoD.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Open meeting notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces that a Federal advisory committee meeting of the Advisory Council on Dependents' Education will take place.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Friday, September 23, 2011, Japan Standard Time at Yokosuka Naval Base, Japan, from 7 a.m. to 12 p.m., Japan Standard Time; and Thursday, September 22, 2011, Eastern Standard Time via Video-teleconference (VTC), from 6 p.m. to 11 p.m., Eastern Standard Time via VTC.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>On September 23, at Yokosuka Naval Base, Japan, and on September 22 at 4040 North Fairfax Drive, Arlington, VA 22203 via VTC.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Dr. Steve Schrankel at (703) 588-3109 or<E T="03">Steve.Schrankel@hq.dodea.edu.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P SOURCE="NPAR">1.<E T="03">Purpose of the Meeting:</E>Recommend to the Acting Director DoDEA, general policies for the operation of the Department of Defense Dependents Schools (DoDDS); to provide the Acting Director with information about effective educational programs and practices that should be considered by DoDDS; and to perform other tasks as may be required by the Secretary of Defense.</P>
        <P>2.<E T="03">Agenda:</E>The meeting agenda will reflect current DoDDS schools operational status, educational practices, and other educational matters that come before the council.</P>
        <P>3.<E T="03">Public's Accessibility to the Meeting:</E>Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165 and the availability of space, this meeting is open to the public. Seating is on a first-come basis. The purpose of the VTC meeting on September 22, 2011, at 6 p.m., Eastern Daylight Time is to provide the public in the United States access to the meeting held in Japan on September 23, 2011, at 7 a.m. Japan Standard Time.</P>
        <P>4.<E T="03">Committee's Point of Contact:</E>Dr. Steve Schrankel at (703) 588-3109, 4040 North  Fairfax Drive, Arlington, VA 22203 or<E T="03">Steve.Schrankel@hq.dodea.edu.</E>
        </P>
        <P>5.<E T="03">Special Accommodations:</E>Individuals requiring special accommodations to access the public meeting should contact Dr. Schrankel at least five (5) business days prior to the meeting so that appropriate arrangements can be made.</P>
        <P>6.<E T="03">Written Statements:</E>Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Advisory Council on Dependents' Education about its mission and functions. Written statements may be submitted at any time or in response to the stated agendas of the planned meeting of the Advisory Council on Dependents' Education.</P>

        <P>All written statements shall be submitted to the Designated Federal Officer (DFO) for the Advisory Council on Dependents' Education, Dr. Patrick A. Dworakowski, 4040 North Fairfax Drive, Arlington, VA 22203;<E T="03">Patrick.Dworakowski@hq.dodea.edu.</E>Statements being submitted in response to the agendas mentioned in this notice must be received by the DFO at the address listed above at least fourteen calendar days prior to the meeting, which is the subject of this notice. Written statements received after this date may not be provided to or considered by the Advisory Council on Dependents' Education until its next meeting.</P>
        <P>The DFO will review all timely submissions with the Advisory Council on Dependents' Education Chairpersons and ensure they are provided to all members of the Advisory Council on Dependents' Education before the meeting that is the subject of this notice.</P>
        <P>
          <E T="03">Oral Statements by the Public to the Membership:</E>Pursuant to 41 CFR 102-3.140(d), time will be allotted for public comments to the Advisory Council on Dependents' Education. Individual comments will be limited to a maximum of five minutes duration. The total time allotted for public comments will not exceed thirty minutes.</P>
        <SIG>
          <DATED>Dated: May 26, 2011.</DATED>
          <NAME>Aaron Siegel,</NAME>
          <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13874 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 5001-06-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
        <SUBAGY>Office of the Secretary</SUBAGY>
        <SUBJECT>Meeting of the Defense Department Advisory Committee on Women in the Services (DACOWITS)</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Department of Defense, DoD.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>Pursuant to Section 10(a), Public Law 92-463, as amended, notice is hereby given of a forthcoming meeting of the Defense Department Advisory Committee on Women in the Services (DACOWITS). The purpose of the meeting is for the Committee to receive briefings from the Sexual Assault Prevention and Response Office on their annual report results and comments on the FY11 NDAA. The Defense Manpower Data Center will give the Committee a briefing on the results of their Workplace and Gender Relations survey. Additionally, the Committee will also receive a status update briefing from the Navy on the integration of women into submarines. Finally, OUSD Military Personnel Policy will brief on the laws and policies that restrict the service of female members and the plans for a new Working Group on women's issues. The meeting is open to the public, subject to the availability of space.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>June 28, 2011, 8:30 a.m.-5 p.m.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Residence Inn Marriott, 550 Army Navy Dr., Arlington, VA 22202.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>MSgt Robert Bowling, USAF, or DACOWITS, 4000 Defense Pentagon, Room 2C548A, Washington, DC 20301-4000.<E T="03">Robert.bowling@osd.mil.</E>Telephone (703) 697-2122. Fax (703) 614-6233.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:<PRTPAGE P="32359"/>
        </HD>
        <HD SOURCE="HD1">Meeting Agenda</HD>
        <HD SOURCE="HD1">Tuesday, 28 June 2011, 8:30 a.m.-5 p.m.</HD>
        <FP SOURCE="FP-1">—Welcome, introductions, and announcements.</FP>
        <FP SOURCE="FP-1">—Receive briefings from the Sexual Assault Prevention and Response Office on 2010 Reports and FY11 NDAA.</FP>
        <FP SOURCE="FP-1">—Receive briefing from Defense Manpower Data Center on survey results on 2010 workplace and gender relations.</FP>
        <FP SOURCE="FP-1">—Receive briefing from Navy on the status of integration of women into submarines.</FP>
        <FP SOURCE="FP-1">—Receive briefings from OUSD Military Personnel Policy on laws and policies restricting service of female service members and plans on Working Group on women's issues.</FP>
        <FP SOURCE="FP-1">—Public Forum.</FP>
        

        <P>Interested persons may submit a written statement for consideration by the Defense Department Advisory Committee on Women in the Services. Individuals submitting a written statement must submit their statement to the Point of Contact listed below at the address detailed in<E T="02">FOR FURTHER INFORMATION CONTACT</E>no later than 5 p.m., Friday, June 24, 2011. If a written statement is not received by Friday, June 24, 2011, prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the Defense Advisory Committee on Women in the Services until its next open meeting. The Designated Federal Officer will review all timely submissions with the Defense Advisory Committee on Women in the Services Chairperson and ensure they are provided to the members of the Defense Advisory Committee on Women in the Services. If members of the public are interested in making an oral statement, a written statement must be submitted as above. After reviewing the written comments, the Chairperson and the Designated Federal Officer will determine who of the requesting persons will be able to make an oral presentation of their issue during an open portion of this meeting or at a future meeting. Determination of who will be making an oral presentation will depend on time available and if the topics are relevant to the Committee's activities. Two minutes will be allotted to persons desiring to make an oral presentation. Oral presentations by members of the public will be permitted only on Tuesday, June 28, 2011 from 4:15 p.m. to 5 p.m. before the full Committee. Number of oral presentations to be made will depend on the number of requests received from members of the public.</P>
        <SIG>
          <DATED>Dated: May 26, 2011.</DATED>
          <NAME>Aaron Siegel,</NAME>
          <TITLE>Alternate OSD Federal Register Liaison, Department of Defense.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13875 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 5001-06-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
        <SUBAGY>Department of the Navy</SUBAGY>
        <DEPDOC>[Docket ID USN-2011-0008]</DEPDOC>
        <SUBJECT>Privacy Act of 1974; System of Records</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Department of the Navy, DoD.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice to delete two systems of records.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Navy is deleting two systems of records notices in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>This proposed action will be effective without further notice on July 6, 2011 unless comments are received which result in a contrary determination.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
          <P>•<E T="03">Federal Rulemaking Portal:</E>
            <E T="03">http://www.regulations.gov.</E>Follow the instructions for submitting comments.</P>
          <P>•<E T="03">Mail:</E>Federal Docket Management System Office, 1160 Defense Pentagon, Washington, DC 20301-1160.</P>
          <P>
            <E T="03">Instructions:</E>All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this<E T="04">Federal Register</E>document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at<E T="03">http://www.regulations.gov</E>as they are received without change, including any personal identifiers or contact information.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Ms. Robin Patterson, FOIA/Privacy Act Policy Branch, Department of the Navy, 2000 Navy Pentagon, Washington, DC 20350-2000, or by phone at (202) 685-6546.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>

        <P>The Department of the Navy systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the<E T="04">Federal Register</E>and are available from the address in<E T="02">FOR FURTHER INFORMATION CONTACT</E>.</P>
        <P>The Department of the Navy proposes to delete two systems of records notices from its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. The proposed deletions are not within the purview of subsection (r) of the Privacy Act of 1974, (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.</P>
        <SIG>
          <DATED>Dated: May 24, 2011.</DATED>
          <NAME>Aaron Siegel,</NAME>
          <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
        </SIG>
        <PRIACT>
          <HD SOURCE="HD1">N12308-1</HD>
          <HD SOURCE="HD2">Deletion:</HD>
          <HD SOURCE="HD2">System Name:</HD>
          <P>Navy Fleet and Family Readiness (FFR) Internship Program (March 10, 2008, 73 FR 12713).</P>
          <HD SOURCE="HD2">Reason:</HD>
          <P>Commander, Navy Installations Command, Department of the Navy, has determined this collection is no longer needed and thus obsolete. Future interns will either be placed as volunteers or temporary flex Non Appropriated Fund (NAF) employees at an installation level. N12308-1, The Navy Fleet and Family Readiness (FFR) Internship Program system of records notice can therefore be deleted.</P>
          <HD SOURCE="HD1">NM12410-1</HD>
          <HD SOURCE="HD2">Deletion:</HD>
          <HD SOURCE="HD2">System Name:</HD>
          <P>MWR Training Student Database (May 31, 2006, 71 FR 30897).</P>
          <HD SOURCE="HD2">Reason:</HD>
          <P>Commander, Navy Installations Command, Department of the Navy, has determined this collection is now taking place under N05230-1, Total Workforce Management Services (TWMS) (October 20, 2010, 75 FR 64715). NM12410-1, MWR Training Student Database system of records notice can therefore be deleted.</P>
          
        </PRIACT>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13873 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 5001-06-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">ELECTION ASSISTANCE COMMISSION</AGENCY>
        <SUBJECT>Sunshine Act Meeting</SUBJECT>
        <PREAMHD>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>U.S. Election Assistance Commission.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of Public Meeting for EAC Board of Advisors (Amended).</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">DATE AND TIME:</HD>
          <P>Monday, June 6, 2011, 8:30 a.m.-5:30 p.m. andTuesday, June 7, 2011, 8:30 a.m.-3:30 p.m.</P>
        </PREAMHD>
        <PREAMHD>
          <PRTPAGE P="32360"/>
          <HD SOURCE="HED">PLACE:</HD>
          <P>Westin Washington, DC, City Center Hotel,1400 M Street NW.,Washington, DC 20005,Phone number (202) 429-1700.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">PURPOSE:</HD>
          <P>The U.S. Election Assistance Commission (EAC) Board of Advisors will meet to receive updates on EAC's program activities and budget. The Board will receive updates on the Voting System Testing and Certification program. The Board will hear updates from a special committee on Defining Issues of Voting System Sustainability. The Board will hear presentations by the National Institute of Standards and Technology (NIST) and the Federal Voting Assistance Program (FVAP) on UOCAVA internet voting and common data format. The Board will receive updates on EAC grants programs including: the Accessible Voting Technology Initiative; and the Pre-Election Logic and Accuracy Testing and Post-Election Audit Initiative. The Board will receive updates on EAC research and studies. The Board will hear a presentation on a Rutgers report on Voter Participation of People with Disabilities in 2010. The Board will hear other committee reports, elect officers and consider motions. The Board will consider other administrative matters.</P>
          <P>Members of the public may observe but not participate in EAC meetings unless this notice provides otherwise. Members of the public may use small electronic audio recording devices to record the proceedings. The use of other recording equipment and cameras requires advance notice to and coordination with the EAC's Communications Office.</P>
          <P>This meeting will be open for public observation.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">STATEMENT OF EXCEPTIONAL CIRCUMSTANCES:</HD>

          <P SOURCE="NPAR">The Monday, May 23, 2011 notice of the EAC Board of Advisors Meeting inadvertently omitted the fact that the notice would published in the<E T="04">Federal Register</E>14 days prior to the dates of the meeting instead of the required 15 days notice. Late notice was unavoidable due to the short timeline following the approval of the meeting agenda and the intent that the notice would publish on Friday, May 20, 2011.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">PERSON TO CONTACT FOR INFORMATION:</HD>
          <P>Bryan Whitener.<E T="03">Telephone:</E>(202) 566-3100.</P>
        </PREAMHD>
        <SIG>
          <NAME>Thomas R. Wilkey,</NAME>
          <TITLE>Executive Director,U.S. Election Assistance Commission.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13984 Filed 6-2-11; 4:15 pm]</FRDOC>
      <BILCOD>BILLING CODE 6820-KF-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
        <DEPDOC>[FRL-9314-3]</DEPDOC>
        <SUBJECT>Casmalia Disposal Site; Notice of Proposed CERCLA Administrative De Minimis Settlement</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Environmental Protection Agency (EPA).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice; correction.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>On April 4, 2011, a published notice of a proposed administrative<E T="03">de minimis</E>settlement concerning the Casmalia Disposal Site in Santa Barbara County, California listed the name of one of the parties to the settlement as “EADS North America” rather than “EADS North America Holdings, Inc.”</P>
        </SUM>
        <PREAMHD>
          <HD SOURCE="HED">FOR MORE INFORMATION CONTACT:</HD>
          <P>Karen Goldberg at (415) 972-3951.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">CORRECTION:</HD>
          <P>In the<E T="04">Federal Register</E>of April 4, 2011, in FR Doc. 2011-7904, 76 FR 18549, page 18550, column 1, correct the name as follows: Manhattan Beach Holding Corp. on its own behalf and on behalf of Fairchild Industries, Inc. and its successors, and on behalf of Fairchild Controls Corporation, Matra Aerospace, Inc., EADS North America, Inc., and EADS North America Holdings, Inc.</P>
        </PREAMHD>
        <SIG>
          <DATED>Dated: May 2, 2011.</DATED>
          <NAME>Nancy Lindsay,</NAME>
          <TITLE>Acting Director, Superfund Division, Region IX.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13877 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6560-50-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">FARM CREDIT ADMINISTRATION</AGENCY>
        <SUBJECT>Farm Credit Administration Board; Sunshine Act; Regular Meeting</SUBJECT>
        <PREAMHD>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Farm Credit Administration.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>Notice is hereby given, pursuant to the Government in the Sunshine Act (5 U.S.C. 552b(e)(3)), of the regular meeting of the Farm Credit Administration Board (Board).</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">DATE AND TIME:</HD>
          <P>The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on June 9, 2011, from 9 a.m. until such time as the Board concludes its business.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090.</P>
        </PREAMHD>
        <PREAMHD>
          <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
          <P>Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. In order to increase the accessibility to Board meetings, persons requiring assistance should make arrangements in advance. The matters to be considered at the meeting are:</P>
        </PREAMHD>
        <HD SOURCE="HD1">Open Session</HD>
        <HD SOURCE="HD2">A. Approval of Minutes</HD>
        <P>• May 12, 2011.</P>
        <HD SOURCE="HD2">B. New Business</HD>
        <P>• Farmer Mac Risk-Based Capital Stress Test, Version 5.0—Advance Notice of Proposed Rulemaking.</P>
        <HD SOURCE="HD2">C. Reports</HD>
        <P>• FCA's Annual Report on the Farm Credit System's Young, Beginning, and Small Farmer Mission Performance: 2010 Results.</P>
        <P>• Semi-Annual Report on Office of Examination Operations.</P>
        <P>• Quarterly Report on Farm Credit System Condition.</P>
        <HD SOURCE="HD1">Closed Session*</HD>
        <HD SOURCE="HD2">Report</HD>
        <P>• Update on Office of Examination Supervisory and Oversight Activities.</P>
        <SIG>
          <DATED>Dated: June 2, 2011.</DATED>
          <NAME>Dale L. Aultman,</NAME>
          <TITLE>Secretary,Farm Credit Administration Board.</TITLE>
        </SIG>
        <EXTRACT>
          <P>*Session Closed-Exempt pursuant to 5 U.S.C. 552b(c)(8) and (9).</P>
        </EXTRACT>
        
      </PREAMB>
      <FRDOC>[FR Doc. 2011-14030 Filed 6-2-11; 4:15 pm]</FRDOC>
      <BILCOD>BILLING CODE 6705-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
        <SUBJECT>Information Collection Being Reviewed by the Federal Communications Commission</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Communications Commission.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act (PRA) of 1995. Comments are requested concerning (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c)<PRTPAGE P="32361"/>ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.</P>
          <P>The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written PRA comments should be submitted on or before August 5, 2011. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>Direct all PRA comments to the Federal Communications Commission via e-mail to<E T="03">PRA@fcc.gov</E>and<E T="03">Cathy.Williams@fcc.gov.</E>
          </P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>For additional information about the information collection, contact Cathy Williams at (202) 418-2918.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>
        <P>
          <E T="03">OMB Control No.:</E>3060-xxxx.</P>
        <P>
          <E T="03">Title:</E>Part 27—Miscellaneous Wireless Communications Services in the 2.3 GHz Band.</P>
        <P>
          <E T="03">Form No.:</E>N/A.</P>
        <P>
          <E T="03">Type of Review:</E>New information collection.</P>
        <P>
          <E T="03">Respondents:</E>Business or other for profit.</P>
        <P>
          <E T="03">Number of Respondents and Responses:</E>158 respondents; 2,406 responses.</P>
        <P>
          <E T="03">Estimated Time per Response:</E>0.5 to 40 hours.</P>
        <P>
          <E T="03">Frequency of Response:</E>Recordkeeping requirement; Third party disclosure requirement, and On occasion reporting requirement.</P>
        <P>
          <E T="03">Obligation to Respond:</E>Required to obtain or retain benefits. The statutory authority for this collection of information is contained in 47 U.S.C. 154, 301, 302(a), 303, 309, 332, 336, and 337.</P>
        <P>
          <E T="03">Total Annual Burden:</E>23,507 hours.</P>
        <P>
          <E T="03">Annual Cost Burden:</E>$928,200.</P>
        <P>
          <E T="03">Privacy Act Impact Assessment:</E>None.</P>
        <P>
          <E T="03">Nature and Extent of Confidentiality:</E>There is no need for confidentiality with this collection of information.</P>
        <P>
          <E T="03">Needs and Uses:</E>The information filed by Wireless Communications Service (WCS) licensees in support of their construction notifications will be used to determine whether licensees have complied with the Commission's performance benchmarks. Further, the information collected by licensees in support of their coordination obligations will help avoid harmful interference to Satellite Digital Audio Radio Service (SDARS), Aeronautical Mobile Telemetry (AMT), and Deep Space Network (DSN) operations in other spectrum bands.</P>
        <SIG>
          <FP>Federal Communications Commission.</FP>
          <NAME>Marlene H. Dortch,</NAME>
          <TITLE>Secretary,Office of the Secretary,Office of Managing Director.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13906 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6712-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">FEDERAL DEPOSIT INSURANCE CORPORATION</AGENCY>
        <SUBJECT>Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or Manager</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Deposit Insurance Corporation.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Update listing of financial institutions in liquidation.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the<E T="04">Federal Register</E>) may be relied upon as “of record” notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992 issue of the<E T="04">Federal Register</E>(57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site at<E T="03">http://www.fdic.gov/bank/individual/failed/banklist.html</E>or contact the Manager of Receivership Oversight in the appropriate service center.</P>
        </SUM>
        <SIG>
          <DATED>Dated: May 31, 2011.</DATED>
          
          <FP>Federal Deposit Insurance Corporation.</FP>
          <NAME>Pamela Johnson,</NAME>
          <TITLE>Regulatory Editing Specialist.</TITLE>
        </SIG>
        <GPOTABLE CDEF="s50,r50,r50,xls24C,11C" COLS="5" OPTS="L2,i1">
          <TTITLE>Institutions in Liquidation</TTITLE>
          <TDESC>In alphabetical order</TDESC>
          <BOXHD>
            <CHED H="1">FDIC Ref. No.</CHED>
            <CHED H="1">Bank name</CHED>
            <CHED H="1">City</CHED>
            <CHED H="1">State</CHED>
            <CHED H="1">Date<LI>closed</LI>
            </CHED>
          </BOXHD>
          <ROW>
            <ENT I="01">10368</ENT>
            <ENT>First Heritage Bank</ENT>
            <ENT>Snohomish</ENT>
            <ENT>WA</ENT>
            <ENT>05/27/2011</ENT>
          </ROW>
        </GPOTABLE>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13862 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6714-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">FEDERAL RESERVE SYSTEM</AGENCY>
        <SUBJECT>Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company</SUBJECT>
        <P>The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).</P>
        <P>The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than June 21, 2011.</P>
        <P>A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:</P>
        <P>1.<E T="03">Teresa L. Keslar, Beatrice, Nebraska,</E>to acquire control of Keystone Investment, Inc., and thereby indirectly acquire control of Bank of Keystone, both in Keystone, Nebraska.</P>

        <P>B. Federal Reserve Bank of San Francisco (Kenneth Binning, Vice President, Applications and<PRTPAGE P="32362"/>Enforcement) 101 Market Street, San Francisco, California 94105-1579:</P>
        <P>1.<E T="03">Castle Creek Capital Partners IV, LP, Castle Creek Advisors</E>
          <E T="03">IV, LLC, Castle Creek Capital IV, LLC, John T. Pietrzak, Pietrzak Advisory Corp., John M. Eggemeyer, JME Advisory Corp., William J. Ruh, Ruh Advisory Corp., Mark G. Merlo, Legions IV Advisory Corp., Joseph Mikesell Thomas, and Mikesell Advisory Corp., all of Rancho Santa Fe, California as a group acting in concert,</E>to acquire control of Intermountain Community Bancorp, and thereby indirectly acquire control of Panhandle State Bank, both of Sandpoint, Idaho.</P>
        <SIG>
          <DATED>Board of Governors of the Federal Reserve System, June 1, 2011.</DATED>
          <NAME>Robert deV. Frierson,</NAME>
          <TITLE>Deputy Secretary of the Board.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13883 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6210-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">FEDERAL RESERVE SYSTEM</AGENCY>
        <SUBJECT>Formations of, Acquisitions by, and Mergers of Bank Holding Companies</SUBJECT>

        <P>The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841<E T="03">et seq.</E>) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.</P>
        <P>The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.</P>
        <P>Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 1, 2011.</P>
        <P>A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President), 701 East Byrd Street, Richmond, Virginia 23261-4528:</P>
        <P>1. ASB Bancorp, Inc., Asheville, North Carolina, to become a bank holding company upon the conversion of Asheville Savings Bank, S.S.B., Asheville, North Carolina, from a mutual to stock form of ownership.</P>
        <SIG>
          <DATED>Board of Governors of the Federal Reserve System, June 1, 2011.</DATED>
          <NAME>Robert deV. Frierson,</NAME>
          <TITLE>Deputy Secretary of the Board.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13882 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 6210-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
        <SUBAGY>Food and Drug Administration</SUBAGY>
        <DEPDOC>[Docket No. FDA-2011-N-0279]</DEPDOC>
        <SUBJECT>Agency Information Collection Activities: Proposed Collection; Reports and Records Under Prescription Drug Marketing Act of 1987</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Food and Drug Administration, HHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the<E T="04">Federal Register</E>concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA).</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Submit either electronic or written comments on the collection of information by August 5, 2011.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>Submit electronic comments on the collection of information to<E T="03">http://www.regulations.gov.</E>Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Elizabeth Berbakos,Office of Information Management,Food and Drug Administration,1350 Piccard Dr.,P150-400B,Rockville, MD 20850,301-796-3792,<E T="03">Elizabeth.Berbakos@fda.hhs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>

        <P>Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the<E T="04">Federal Register</E>concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.</P>
        <P>With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.</P>
        <HD SOURCE="HD1">Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements—21 CFR Part 203 (OMB Control Number 0910-0435)—Extension</HD>

        <P>FDA is requesting OMB approval under the PRA (44 U.S.C. 3501-3520) for the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 100-293). PDMA was intended to ensure that drug products purchased by consumers are safe and effective and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold.<PRTPAGE P="32363"/>
        </P>
        <P>PDMA was enacted by Congress because there were insufficient safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs, and that a wholesale drug diversion submarket had developed that prevented effective control over the true sources of drugs.</P>
        <P>Congress found that large amounts of drugs had been reimported into the United States as U.S. goods returned causing a health and safety risk to U.S. consumers because the drugs may become subpotent or adulterated during foreign handling and shipping. Congress also found that a ready market for prescription drug reimports had been the catalyst for a continuing series of frauds against U.S. manufacturers and had provided the cover for the importation of foreign counterfeit drugs.</P>
        <P>Congress also determined that the system of providing drug samples to physicians through manufacturers' representatives had resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals.</P>
        <P>The bulk resale of below-wholesale priced prescription drugs by health care entities for ultimate sale at retail also helped to fuel the diversion market and was an unfair form of competition to wholesalers and retailers who had to pay otherwise prevailing market prices.</P>
        <P>FDA is requesting OMB approval for the following reporting and recordkeeping requirements:</P>
        <GPOTABLE CDEF="s100,r150" COLS="2" OPTS="L2,p1,8/9,i1">
          <TTITLE>Table 1—Reporting Requirements</TTITLE>
          <BOXHD>
            <CHED H="1"/>
            <CHED H="1"/>
          </BOXHD>
          <ROW>
            <ENT I="01">21 CFR 203.11</ENT>
            <ENT>Applications for reimportation to provide emergency medical care.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.30(a)(1) and (b)</ENT>
            <ENT>Drug sample requests (drug samples distributed by mail or common carrier).</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.30(a)(3), (a)(4), and (c)</ENT>
            <ENT>Drug sample receipts (receipts for drug samples distributed by mail or common carrier).</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.31(a)(1) and (b)</ENT>
            <ENT>Drug sample requests (drug samples distributed by means other than the mail or a common carrier).</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.31(a)(3), (a)(4), and (c)</ENT>
            <ENT>Drug sample receipts (drug samples distributed by means other than the mail or a common carrier).</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.37(a)</ENT>
            <ENT>Investigation of falsification of drug sample records.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.37(b)</ENT>
            <ENT>Investigation of a significant loss or known theft of drug samples.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.37(c)</ENT>
            <ENT>Notification that a representative has been convicted of certain offenses involving drug samples.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.37(d)</ENT>
            <ENT>Notification of the individual responsible for responding to a request for information about drug samples.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.39(g)</ENT>
            <ENT>Preparation by a charitable institution of a reconciliation report for donated drug samples.</ENT>
          </ROW>
        </GPOTABLE>
        <GPOTABLE CDEF="s100,r150" COLS="2" OPTS="L2,p1,8/9,i1">
          <TTITLE>Table 2—Recordkeeping Requirements</TTITLE>
          <BOXHD>
            <CHED H="1"/>
            <CHED H="1"/>
          </BOXHD>
          <ROW>
            <ENT I="01">21 CFR 203.23(a) and (b)</ENT>
            <ENT>Credit memo for returned drugs.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.23(c)</ENT>
            <ENT>Documentation of proper storage, handling, and shipping conditions for returned drugs.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.30(a)(2) and 203.31(a)(2)</ENT>
            <ENT>Verification that a practitioner requesting a drug sample is licensed or authorized by the appropriate State authority to prescribe the product.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.31(d)(1) and (d)(2)</ENT>
            <ENT>Contents of the inventory record and reconciliation report required for drug samples distributed by representatives.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.31(d)(4)</ENT>
            <ENT>Investigation of apparent discrepancies and significant losses revealed through the reconciliation report.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.31(e)</ENT>
            <ENT>Lists of manufacturers' and distributors' representatives.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.34</ENT>
            <ENT>Written policies and procedures describing administrative systems.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.37(a)</ENT>
            <ENT>Report of investigation of falsification of drug sample records.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.37(b)</ENT>
            <ENT>Report of investigation of significant loss or known theft of drug samples.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.38(b)</ENT>
            <ENT>Records of drug sample distribution identifying lot or control numbers of samples distributed. (The information collection in 21 CFR 203.38(b) is already approved under OMB Control Number 0910-0139).</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.39(d)</ENT>
            <ENT>Records of drug samples destroyed or returned by a charitable institution.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.39(e)</ENT>
            <ENT>Record of drug samples donated to a charitable institution.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.39(f)</ENT>
            <ENT>Records of donation and distribution or other disposition of donated drug samples.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.39(g)</ENT>
            <ENT>Inventory and reconciliation of drug samples donated to charitable institutions.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.50(a)</ENT>
            <ENT>Drug origin statement.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.50(b)</ENT>
            <ENT>Retention of drug origin statement for 3 years.</ENT>
          </ROW>
          <ROW>
            <ENT I="01">21 CFR 203.50(d)</ENT>
            <ENT>List of authorized distributors of record.</ENT>
          </ROW>
        </GPOTABLE>

        <P>The reporting and recordkeeping requirements are intended to help achieve the following goals: (1) To ban the reimportation of prescription drugs produced in the United States, except when reimported by the manufacturer or under FDA authorization for emergency medical care; (2) to ban the sale, purchase, or trade, or the offer to sell, purchase, or trade, of any prescription drug sample; (3) to limit the distribution of drug samples to practitioners licensed or authorized to prescribe such drugs or to pharmacies of hospitals or other health care entities at the request of a licensed or authorized practitioner; (4) to require licensed or authorized practitioners to request prescription drug samples in writing; (5) to mandate storage, handling, and recordkeeping requirements for prescription drug samples; (6) to prohibit, with certain exceptions, the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or other health care entities, or which were donated or supplied at a reduced price to a charitable organization; (7) to require unauthorized wholesale distributors to provide, prior to the wholesale distribution of a prescription drug to another wholesale distributor or<PRTPAGE P="32364"/>retail pharmacy, a statement identifying each prior sale, purchase, or trade of the drug.</P>
        <P>FDA estimates the burden of this collection of information as follows:</P>
        <GPOTABLE CDEF="s60,12,12,12,12,9.2" COLS="6" OPTS="L2,i1">
          <TTITLE>Table 3—Estimated Annual Reporting Burden<SU>1</SU>
          </TTITLE>
          <BOXHD>
            <CHED H="1">21 CFR section</CHED>
            <CHED H="1">Number of<LI>respondents</LI>
            </CHED>
            <CHED H="1">Number of<LI>responses</LI>
              <LI>per</LI>
              <LI>respondent</LI>
            </CHED>
            <CHED H="1">Total annual responses</CHED>
            <CHED H="1">Average<LI>burden per</LI>
              <LI>response</LI>
              <LI>(in hours)<SU>2</SU>
              </LI>
            </CHED>
            <CHED H="1">Total hours</CHED>
          </BOXHD>
          <ROW>
            <ENT I="01">203.11</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
            <ENT>30/60</ENT>
            <ENT>.50</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.30(a)(1) and (b)</ENT>
            <ENT>61,961</ENT>
            <ENT>12</ENT>
            <ENT>743,532</ENT>
            <ENT>4/60</ENT>
            <ENT>44,612</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.30(a)(3), (a)(4), and (c)</ENT>
            <ENT>61,961</ENT>
            <ENT>12</ENT>
            <ENT>743,532</ENT>
            <ENT>4/60</ENT>
            <ENT>44,612</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.31(a)(1) and (b)</ENT>
            <ENT>232,355</ENT>
            <ENT>135</ENT>
            <ENT>31,367,925</ENT>
            <ENT>2/60</ENT>
            <ENT>1,254,717</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.31(a)(3), (a)(4), and (c)</ENT>
            <ENT>232,355</ENT>
            <ENT>135</ENT>
            <ENT>31,367,925</ENT>
            <ENT>2/60</ENT>
            <ENT>941,038</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.37(a)</ENT>
            <ENT>50</ENT>
            <ENT>4</ENT>
            <ENT>200</ENT>
            <ENT>15/60</ENT>
            <ENT>50</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.37(b)</ENT>
            <ENT>50</ENT>
            <ENT>40</ENT>
            <ENT>2,000</ENT>
            <ENT>15/60</ENT>
            <ENT>500</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.37(c)</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.37(d)</ENT>
            <ENT>50</ENT>
            <ENT>1</ENT>
            <ENT>50</ENT>
            <ENT>5/60</ENT>
            <ENT>4</ENT>
          </ROW>
          <ROW RUL="n,s">
            <ENT I="01">203.39(g)</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
            <ENT>1</ENT>
          </ROW>
          <ROW>
            <ENT I="03">Total</ENT>
            <ENT/>
            <ENT/>
            <ENT/>
            <ENT/>
            <ENT>2,285,535.50</ENT>
          </ROW>
          <TNOTE>
            <SU>1</SU>There are no capital costs or operating and maintenance costs associated with this collection of information.</TNOTE>
          <TNOTE>
            <SU>2</SU>Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format “[number of minutes per response]/60”.</TNOTE>
        </GPOTABLE>
        <GPOTABLE CDEF="s60,12,12,12,12,12" COLS="6" OPTS="L2,i1">
          <TTITLE>Table 4—Estimated Annual Recordkeeping Burden<SU>1</SU>
          </TTITLE>
          <BOXHD>
            <CHED H="1">21 CFR section</CHED>
            <CHED H="1">Number of<LI>recordkeepers</LI>
            </CHED>
            <CHED H="1">Number of<LI>records per</LI>
              <LI>recordkeeper</LI>
            </CHED>
            <CHED H="1">Total annual records</CHED>
            <CHED H="1">Average<LI>burden per</LI>
              <LI>recordkeeping</LI>
              <LI>(in hours)<SU>2</SU>
              </LI>
            </CHED>
            <CHED H="1">Total hours</CHED>
          </BOXHD>
          <ROW>
            <ENT I="01">203.23(a) and (b)</ENT>
            <ENT>31,676</ENT>
            <ENT>5</ENT>
            <ENT>158,380</ENT>
            <ENT>15/60</ENT>
            <ENT>39,595</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.23(c)</ENT>
            <ENT>31,676</ENT>
            <ENT>5</ENT>
            <ENT>158,380</ENT>
            <ENT>5/60</ENT>
            <ENT>12,670</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.30(a)(2) and 203.31(a)(2)</ENT>
            <ENT>2,208</ENT>
            <ENT>100</ENT>
            <ENT>220,800</ENT>
            <ENT>30/60</ENT>
            <ENT>110,400</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.31(d)(1) and (d)(2)</ENT>
            <ENT>2,208</ENT>
            <ENT>1</ENT>
            <ENT>2,208</ENT>
            <ENT>40</ENT>
            <ENT>88,320</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.31(d)(4)</ENT>
            <ENT>442</ENT>
            <ENT>1</ENT>
            <ENT>442</ENT>
            <ENT>24</ENT>
            <ENT>10,608</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.31(e)</ENT>
            <ENT>2,208</ENT>
            <ENT>1</ENT>
            <ENT>2,208</ENT>
            <ENT>1</ENT>
            <ENT>2,208</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.34</ENT>
            <ENT>90</ENT>
            <ENT>1</ENT>
            <ENT>90</ENT>
            <ENT>40</ENT>
            <ENT>3,600</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.37(a)</ENT>
            <ENT>50</ENT>
            <ENT>4</ENT>
            <ENT>200</ENT>
            <ENT>6</ENT>
            <ENT>1,200</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.37(b)</ENT>
            <ENT>50</ENT>
            <ENT>40</ENT>
            <ENT>2,000</ENT>
            <ENT>6</ENT>
            <ENT>1,200</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.39(d)</ENT>
            <ENT>65</ENT>
            <ENT>1</ENT>
            <ENT>65</ENT>
            <ENT>1</ENT>
            <ENT>65</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.39(e)</ENT>
            <ENT>3,221</ENT>
            <ENT>1</ENT>
            <ENT>3,221</ENT>
            <ENT>30/60</ENT>
            <ENT>1,610</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.39(f)</ENT>
            <ENT>3,221</ENT>
            <ENT>1</ENT>
            <ENT>3,221</ENT>
            <ENT>8</ENT>
            <ENT>25,768</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.39(g)</ENT>
            <ENT>3,221</ENT>
            <ENT>1</ENT>
            <ENT>3,221</ENT>
            <ENT>8</ENT>
            <ENT>25,768</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.50(a)</ENT>
            <ENT>125</ENT>
            <ENT>100</ENT>
            <ENT>12,500</ENT>
            <ENT>10/60</ENT>
            <ENT>2,125</ENT>
          </ROW>
          <ROW>
            <ENT I="01">203.50(b)</ENT>
            <ENT>125</ENT>
            <ENT>100</ENT>
            <ENT>12,500</ENT>
            <ENT>30/60</ENT>
            <ENT>6,250</ENT>
          </ROW>
          <ROW RUL="n,s">
            <ENT I="01">203.50(d)</ENT>
            <ENT>691</ENT>
            <ENT>1</ENT>
            <ENT>691</ENT>
            <ENT>2</ENT>
            <ENT>1,382</ENT>
          </ROW>
          <ROW>
            <ENT I="03">Total</ENT>
            <ENT/>
            <ENT/>
            <ENT/>
            <ENT/>
            <ENT>332,769</ENT>
          </ROW>
          <TNOTE>
            <SU>1</SU>There are capital costs or operating and maintenance costs associated with this collection of information.</TNOTE>
          <TNOTE>
            <SU>2</SU>Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format “[number of minutes per response]/60”.</TNOTE>
        </GPOTABLE>
        <SIG>
          <DATED>Dated: May 24, 2011.</DATED>
          <NAME>Leslie Kux,</NAME>
          <TITLE>Acting Assistant Commissioner for Policy.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13442 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4160-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
        <SUBAGY>Food and Drug Administration</SUBAGY>
        <DEPDOC>[Docket No. FDA-2011-N-0375]</DEPDOC>
        <SUBJECT>Collaboration in Regulatory Science and Capacity To Advance Global Access to Safe Vaccines and Biologicals</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Food and Drug Administration, HHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award of a cooperative agreement to the World Health Organization (WHO) in support of collaboration in regulatory science and capacity of National Regulatory Authorities (NRAs) to advance global access to safe and effective vaccines and other biologicals that meet international standards. The goal of FDA's Center for Biologics Evaluation and Research (FDA/CBER) is to enhance technical collaboration and cooperation between FDA, WHO, and its Member States.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>Important dates are as follows:</P>
          <P>1. The application due date is July 8, 2011.</P>
          <P>2. The anticipated start date is August 15, 2011.<PRTPAGE P="32365"/>
          </P>
          <P>3. The expiration date is July 9, 2011.</P>
        </EFFDATE>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:</HD>
          

          <FP SOURCE="FP-1">Gopa Raychaudhuri, Center for Biologics and Evaluation and Research, Liaison to the World Health Organization, Food and Drug Administration, 1401 Rockville Pike (HFM-30), suite 200N, Rockville, MD 20852, 301-827-6352,<E T="03">gopa.raychaudhuri@fda.hhs.gov;</E>
          </FP>

          <FP SOURCE="FP-1">Leslie Haynes, Foreign Regulatory Capacity Building Coordinator, International Affairs, Food and Drug Administration, 1401 Rockville Pike (HFM-30), suite 200N, Rockville, MD 20852, 301-827-3114,<E T="03">leslie.haynes@fda.hhs.gov;</E>or</FP>

          <FP SOURCE="FP-1">Vieda Hubbard, Grants Management Specialist, Office of Acquisitions and Grants Services, Food and Drug Administration, 5630 Fishers Lane (HFA 500), rm. 2141, Rockville, MD 20857, 301-827-7177,<E T="03">vieda.hubbard@fda.hhs.gov.</E>
          </FP>
          

          <P>For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at<E T="03">http://www.grants.gov</E>and/or<E T="03">http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm251665.htm.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>
        <HD SOURCE="HD1">I. Funding Opportunity Description</HD>
        <FP>RFA-FD-11-011.</FP>
        <FP>93.103.</FP>
        <HD SOURCE="HD2">A. Background</HD>
        <P>The U.S. Department of Health and Human Services (HHS) has invested significantly in developing sustainable global influenza vaccines production capacity. These financial and intellectual investments in vaccine development and manufacture should not be made in a regulatory vacuum. Adequate regulatory oversight is essential in assuring the safety, efficacy and quality of vaccines.</P>
        <P>WHO is the directing and coordinating authority for health within the United Nations (U.N.) system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. It is the only organization with the mandate, technical expertise, and broad reach to meet the stated objectives.</P>

        <P>WHO plays a key role in establishing the WHO International Biological Reference Preparations and in developing WHO guidelines and recommendations on the production and control of influenza and other vaccines, biological products and technologies. These norms and standards are based on wide scientific consultation and on international consensus and are intended to ensure the consistent quality and safety of biological medicines and related<E T="03">in vitro</E>diagnostic tests worldwide. Advancement of these efforts requires close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers, and expert laboratories worldwide.</P>
        <P>FDA/CBER has worked with WHO in the global community to improve human public health worldwide for many years. A core principle of FDA/CBER's international engagements to protect global public health is the fact that efforts to address infectious disease threats anywhere in the world translates to protection of the U.S. population which benefits U.S. public health overall. Indeed, in 2011, improving global public health through international collaboration, including promoting research and information sharing, is one of FDA/CBER's six primary strategic goals. FDA generally, and more specifically FDA/CBER, has long-standing productive collaborations with WHO in the area of vaccines and other biologics.</P>
        <P>FDA/CBER is a Pan American Health Organization (PAHO)/WHO Collaborating Center for Biological Standardization. In this capacity, FDA/CBER contributes significantly through participation as expert consultants, as members of advisory and other expert committees, in laboratory collaborations for establishing physical standards, and other activities. An important additional area of work is FDA/CBER's engagement with the WHO Vaccine Prequalification Program. The WHO provides advice to the United Nations Children's Fund (UNICEF) and other United Nations (U.N.) Agencies on the acceptability of vaccines considered for purchase by such Agencies for vaccination programs which they administer globally. In 2009, FDA/CBER was assessed by WHO and recognized as a functional national regulatory authority (NRA). FDA entered into a confidentiality arrangement with WHO/QSS to enable FDA/CBER to serve as a reference NRA for the Vaccine Prequalification Program, and FDA/CBER is currently a reference NRA for eight U.S. licensed vaccines including five influenza vaccines.</P>
        <P>The establishment of strong regulatory systems is very important for FDA's ability to fulfill its mission to better monitor and ensure the safety of the supply chain for food, feed, medical products, and cosmetics that enter the United States from other parts of the world. Strengthening regulatory capacity in the developing world is equally important for improving the health and quality of life of individuals and communities in those countries. Strong regulatory systems reinforce and secure public and private investments in development and manufacture of new drugs and vaccines, as well as agriculture and food production—all of which are vulnerable in the absence of functional regulatory frameworks.</P>
        <P>FDA, with other U.S. Government Agencies at HHS, WHO, and other regulatory counterparts, are working to strategize on approaches to enhance the regulatory capabilities of NRAs in developing countries so that they can meet the needs for providing oversight of vaccines manufactured in their countries, specifically influenza vaccines. Sustainable vaccine production capacity cannot be achieved in the absence of robust and functional national regulatory systems. Thus, investments for improving manufacturing facilities must be accompanied in parallel with strengthening regulatory oversight for the manufactured products. Additionally, NRAs are encouraged to build relationships with the policymakers to gain support so that advancements in regulatory capabilities in these countries can be sustained. The aim is to bolster resources for regulatory oversight, thus maximizing the returns on total investments with the production and availability of high quality, effective influenza vaccines that can be deployed worldwide quickly and equitably in future pandemics. In doing so, it is anticipated that strengthening regulatory capacity will benefit the broader arena of access to, and supply of, vaccines globally.</P>
        <HD SOURCE="HD2">B. Research Objectives</HD>
        <P>The project has the following goals:</P>

        <P>• Contribute to the knowledge base of the current state of regulatory oversight of influenza and other vaccines and biologicals by supporting analysis, synthesis, and application of assessments of associated regulatory frameworks and processes in select countries/regions. For example, this could include but is not limited to, analyses and synthesis of existing data from assessments of vaccine regulatory capabilities of different NRAs, and new applications of assessment frameworks to specific areas, such as pharmacovigilance (<E T="03">e.g.,</E>following vaccination with seasonal or pandemic influenza vaccines). Expected outputs<PRTPAGE P="32366"/>could include analyses, reports and data-driven strategy papers, among others.</P>

        <P>• Enable the timely and effective sharing of scientific findings and data,<E T="03">e.g.,</E>on safety and effectiveness of adjuvanted influenza and other vaccines and other emerging technologies in support of developing WHO guidance where appropriate, the utility of new technologies for assessment of product safety, among other areas.</P>
        <P>• Support the sharing and application of knowledge, data, and information through active participation in regional and global networks, such as the African Vaccine Regulatory Forum (AVAREF) and the Developing Countries' Vaccine Regulators Network (DCVRN).</P>
        <HD SOURCE="HD2">C. Eligibility Information</HD>
        <P>The following organizations/institutions are eligible to apply: The World Health Organization.</P>
        <HD SOURCE="HD1">II. Award Information/Funds Available</HD>
        <HD SOURCE="HD2">A. Award Amount</HD>
        <P>FDA/CBER anticipates providing in Fiscal Year (FY) 2011 up to $800,000 (total costs including indirect costs for one award subject to availability of funds) in support of this project. With the possibility of four additional years of support up to $2,000,000 of funding contingent upon successful performance and the availability of funding.</P>
        <HD SOURCE="HD2">B. Length of Support</HD>
        <P>The support will be 1 year with the possibility of an additional 4 years of noncompetitive support. Continuation beyond the first year will be based on satisfactory performance during the preceding year, receipt of a noncompeting continuation application and available Federal FY appropriations.</P>
        <HD SOURCE="HD1">III. Paper Application, Registration, and Submission Information</HD>

        <P>To submit a paper application in response to this FOA, applicants should first review the full announcement located at<E T="03">http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm251665.htm</E>and/or<E T="03">http://www.grants.gov.</E>(FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the<E T="04">Federal Register</E>.) Persons interested in applying for a grant may obtain an application at<E T="03">http://grants.nih.gov/grants/funding/phs398/phs398.html.</E>For all paper application submissions, the following steps are required:</P>
        <P>• Step 1: Obtain a Dun and Bradstreet (DUNS) Number.</P>
        <P>• Step 2: Register With Central Contractor Registration.</P>
        <P>• Step 3: Register With Electronic Research Administration (eRA) Commons.</P>
        <P>Steps 1 and 2, in detail, can be found at<E T="03">http://www07.grants.gov/applicants/organization_registration.jsp.</E>Step 3, in detail, can be found at<E T="03">https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp.</E>After you have followed these steps, submit paper applications to: Vieda Hubbard, Grants Management, 5630 Fishers Lane (HFA-500), rm. 1079, Rockville, MD 20857 and Leslie Haynes, Center for Biologics Evaluation and Research, Office of the Director, 1401 Rockville Pike (HFM-30), suite 200N, Rockville, Maryland 20852-1448.</P>
        <SIG>
          <DATED>Dated: May 31, 2011.</DATED>
          <NAME>Leslie Kux,</NAME>
          <TITLE>Acting Assistant Commissioner for Policy.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13885 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4160-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
        <SUBAGY>Food and Drug Administration</SUBAGY>
        <DEPDOC>[Docket Nos. FDA-2007-P-0347 formerly 2007P-0431/CP1 and FDA-2010-P-0505]</DEPDOC>
        <SUBJECT>Determination That ORLAAM (Levomethadyl Acetate Hydrochloride) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Food and Drug Administration, HHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Food and Drug Administration (FDA) has determined that ORLAAM (levomethadyl acetate hydrochloride (HCl)) oral solution, 10 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levomethadyl acetate HCl oral solution, 10 mg/mL, if all other legal and regulatory requirements are met.</P>
        </SUM>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Sandra Park, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6221, Silver Spring, MD 20993-0002, 301-796-3601.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.</P>
        <P>The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug.</P>
        <P>ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, is the subject of NDA 20-315, held by Roxane Laboratories, Inc. (Roxane), and approved on July 9, 1993. ORLAAM is indicated for the management of opiate dependence, reserved for use in treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for opiate addiction, either because of insufficient effectiveness or the inability to achieve effective dose due to intolerable adverse effects from those drugs.</P>

        <P>In a letter dated April 10, 2003, Roxane notified FDA that ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book. In the<E T="04">Federal Register</E>of November 7, 2007 (72 FR 62858), FDA<PRTPAGE P="32367"/>announced that it was withdrawing approval of NDA 20-315, effective December 7, 2007.</P>
        <P>Charles O'Keeffe of the Virginia Commonwealth University School of Medicine submitted two citizen petitions, one dated October 31, 2007 (Docket No. FDA-2007-P-0347), and the second dated September 22, 2010 (Docket No. FDA-2010-P-0505), under 21 CFR 10.30, requesting that the agency determine whether ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, was withdrawn from sale for reasons of safety or effectiveness.</P>
        <P>After considering the citizen petition and reviewing agency records, FDA has determined under § 314.161 that ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.</P>
        <P>Accordingly, the agency will continue to list ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, may be approved by the agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling.</P>
        <SIG>
          <DATED>Dated: May 31, 2011.</DATED>
          <NAME>Leslie Kux,</NAME>
          <TITLE>Acting Assistant Commissioner for Policy.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13884 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4160-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
        <SUBAGY>Food and Drug Administration</SUBAGY>
        <DEPDOC>[Docket No. FDA-1999-D-0742 (formerly Docket No. 1999D-4396)]</DEPDOC>
        <SUBJECT>Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Correction</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Food and Drug Administration, HHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice; correction.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>The Food and Drug Administration (FDA) is correcting a notice that appeared in the<E T="04">Federal Register</E>of May 24, 2011 (76 FR 30175). The document announced the availability of a draft guidance entitled “ Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.”The document was published with an incorrect docket number. This document corrects that error.</P>
        </SUM>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Joyce Strong, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3208, Silver Spring, MD 20993-0002, 301-796-9148.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>In FR Doc. 2011-12623, appearing on page 30175, in the<E T="04">Federal Register</E>of Tuesday, May 24, 2011, the following correction is made:</P>
        <P>1. On page 30175, in the second column, in the Docket No. heading, “[Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792)” is corrected to read “[Docket No. FDA-1999-D-0742] (formerly Docket No. 1999D-4396)”.</P>
        <SIG>
          <DATED>Dated: May 31, 2011.</DATED>
          <NAME>Leslie Kux,</NAME>
          <TITLE>Acting Assistant Commissioner for Policy.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13871 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4160-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Docket ID FEMA-2011-0013; OMB No. 1660-0106]</DEPDOC>
        <SUBJECT>Agency Information Collection Activities, Proposed Collection; Comment Request; Integrated Public Alert and Warning Systems (IPAWS) Inventory</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed revision of a continuing information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the proposed revision of the information collection concerning public alert and warning systems at the Federal, State, territorial, Tribal and local levels of government which is necessary for the inventory and evaluation and assessment of existing public alert and warning resources and their integration with the Integrated Public Alert and Warning System.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Comments must be submitted on or before August 5, 2011.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:</P>
          <P>(1)<E T="03">Online.</E>Submit comments at<E T="03">http://www.regulations.gov</E>under Docket ID FEMA-2011-0013. Follow the instructions for submitting comments.</P>
          <P>(2)<E T="03">Mail.</E>Submit written comments to Docket Manager, Office of Chief Counsel, DHS/FEMA, 500 C Street, SW., Room 835, Washington, DC 20472-3100.</P>
          <P>(3)<E T="03">Facsimile.</E>Submit comments to (703) 483-2999.</P>
          <P>(4)<E T="03">E-mail.</E>Submit comments to<E T="03">FEMA-POLICY@dhs.gov.</E>Include Docket ID FEMA-2011-0013 in the subject line.</P>

          <P>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<E T="03">http://www.regulations.gov,</E>and will include any personal information you provide. Therefore,<PRTPAGE P="32368"/>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<E T="03">http://www.regulations.gov.</E>
          </P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Vincent Dumas, Business Operations Specialist, National Continuity Program IPAWS Division, FEMA, (202) 646-4269 for additional information. You may contact the Records Management Division for copies of the proposed collection of information at facsimile number (202) 646-3347 or<E T="03">e-mail address: FEMA-Information-Collections-Management@dhs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>Presidential Executive Order 13407 establishes the policy for an effective, reliable, integrated, flexible, and comprehensive system to alert and warn the American people in situations of war, terrorist attack, natural disaster, or other hazards to public safety and well being. The Executive Order requires that DHS establish an inventory of public alert and warning resources, capabilities, and the degree of integration at the Federal, State, territorial, Tribal, and local levels of government. The Integrated Public Alert and Warning System (IPAWS) implements the requirements of the Executive Order. The information collected has, and will continue to consist of the public alert and warning systems, as well as the communication systems being used for collaboration and situational awareness at the Local Emergency Operations Center (EOC) level and higher. This information will help FEMA identify the technologies currently in use or desired for inclusion into IPAWS.</P>
        <HD SOURCE="HD1">Collection of Information</HD>
        <P>
          <E T="03">Title:</E>Integrated Public Alert and Warning Systems (IPAWS) Inventory.</P>
        <P>
          <E T="03">Type of Information Collection:</E>Revision of currently approved collection.</P>
        <P>
          <E T="03">OMB Number:</E>1660-0106.</P>
        <P>
          <E T="03">Form Titles and Numbers:</E>FEMA Form 142-1-1, IPAWS Inventory.</P>
        <P>
          <E T="03">Abstract:</E>FEMA will be conducting an inventory, evaluation and assessment of the capabilities of Federal, State, territorial, Tribal, and local government alert and warning systems. The IPAWS Inventory and Evaluation Survey collects data that will facilitate the integration of public alert and warning systems. It also reduces Federal planning costs by leveraging existing State systems.</P>
        <P>
          <E T="03">Affected Public:</E>State, local, territorial, and Tribal Government.</P>
        <P>
          <E T="03">Estimated Total Annual Burden Hours:</E>5,796 hours.</P>
        <GPOTABLE CDEF="s60,12,12,xs48,12,12" COLS="6" OPTS="L2,i1">
          <TTITLE>Annual Hour Burden</TTITLE>
          <BOXHD>
            <CHED H="1">Data collection activity/instrument</CHED>
            <CHED H="1">Number of<LI>respondents</LI>
            </CHED>
            <CHED H="2">(A)</CHED>
            <CHED H="1">Frequency of responses</CHED>
            <CHED H="2">(B)</CHED>
            <CHED H="1">Hour burden per response</CHED>
            <CHED H="2">(C)</CHED>
            <CHED H="1">Annual<LI>responses</LI>
            </CHED>
            <CHED H="2">(D) = (A × B)</CHED>
            <CHED H="1">Total annual burden hours</CHED>
            <CHED H="2">(C × D)</CHED>
          </BOXHD>
          <ROW RUL="n,s">
            <ENT I="01">FEMA Form 142-1-1, IPAWS Inventory and Evaluation Survey</ENT>
            <ENT>1,932</ENT>
            <ENT>1</ENT>
            <ENT>3 hours (180 min)</ENT>
            <ENT>1,932</ENT>
            <ENT>5,796</ENT>
          </ROW>
          <ROW>
            <ENT I="03">Total</ENT>
            <ENT>1,932</ENT>
            <ENT/>
            <ENT>3 hours (180 min)</ENT>
            <ENT>1,932</ENT>
            <ENT>5,796</ENT>
          </ROW>
        </GPOTABLE>
        <P>
          <E T="03">Estimated Cost:</E>There are no annual start-up or capital costs.</P>
        <HD SOURCE="HD1">Comments</HD>
        <P>Comments may be submitted as indicated in the<E T="02">ADDRESSES</E>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 T="03">e.g.,</E>permitting electronic submission of responses.</P>
        <SIG>
          <DATED>Dated: May 11, 2011.</DATED>
          <NAME>Lesia M. Banks,</NAME>
          <TITLE>Director, Records Management Division, Mission Support Bureau, Federal Emergency Management Agency, Department of Homeland Security.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13141 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9110-14-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-3320-EM; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Mississippi; Emergency and Related Determinations</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This is a notice of the Presidential declaration of an emergency for the State of Mississippi (FEMA-3320-EM), dated May 4, 2011, and related determinations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 4, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>Notice is hereby given that, in a letter dated May 4, 2011, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:</P>
        
        <EXTRACT>
          <P>I have determined that the emergency conditions in certain areas of the State of Mississippi resulting from flooding beginning on April 27, 2011, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (“the Stafford Act”). Therefore, I declare that such an emergency exists in the State of Mississippi.</P>

          <P>You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance emergency<PRTPAGE P="32369"/>protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program. This assistance excludes regular time costs for subgrantees' regular employees.</P>
          <P>Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.</P>
          <P>Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.</P>
        </EXTRACT>
        
        <P>The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Terry L. Quarles, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.</P>
        <P>The following areas of the State of Mississippi have been designated as adversely affected by this declared emergency:</P>
        
        <EXTRACT>
          <P>Adams, Bolivar, Claiborne, Coahoma, DeSoto, Issaquena, Jefferson, Tunica, Warren, Washington, and Wilkinson Counties for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13896 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-3321-EM; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Tennessee; Emergency and Related Determinations</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This is a notice of the Presidential declaration of an emergency for the State of Tennessee (FEMA-3321-EM), dated May 4, 2011, and related determinations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 4, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>Notice is hereby given that, in a letter dated May 4, 2011, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:</P>
        
        <EXTRACT>

          <P>I have determined that the emergency conditions in certain areas of the State of Tennessee resulting from flooding beginning on April 26, 2011, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121<E T="03">et seq.</E>(“the Stafford Act”). Therefore, I declare that such an emergency exists in the State of Tennessee.</P>
          <P>You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program. This assistance excludes regular time costs for subgrantees' regular employees.</P>
          <P>Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.</P>
          <P>Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.</P>
        </EXTRACT>
        
        <P>The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, W. Montague Winfield, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.</P>
        <P>The following areas of the State of Tennessee have been designated as adversely affected by this declared emergency:</P>
        
        <EXTRACT>
          <P>Dyer, Lake, Shelby, and Stewart Counties for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13913 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-3318-EM; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>North Dakota; Amendment No. 4 to Notice of an Emergency Declaration</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This notice amends the notice of an emergency declaration for the State of North Dakota (FEMA-3318-EM), dated April 7, 2011, and related determinations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 28, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <PRTPAGE P="32370"/>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of an emergency declaration for the State of North Dakota is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared an emergency by the President in his declaration of April 7, 2011.</P>
        
        <EXTRACT>
          <P>Burleigh, Emmons, McLean, Mercer, Morton, Oliver, and Sioux Counties and the portion of the Standing Rock Reservation within the State of North Dakota for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13916 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-1976-DR; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Kentucky; Amendment No. 8 to Notice of a Major Disaster Declaration</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-1976-DR), dated May 4, 2011, and related determinations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 26, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 4, 2011.</P>
        
        <EXTRACT>
          <P>Pike County for Individual Assistance.</P>
          <P>Ballard, Daviess, Henderson, Lawrence, and McLean Counties for Individual Assistance, (already designated for Public Assistance, including direct Federal assistance).</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13895 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-1976-DR; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Kentucky; Amendment No. 7 to Notice of a Major Disaster Declaration</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-1976-DR), dated May 4, 2011, and related determinations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 25, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 4, 2011.</P>
        
        <EXTRACT>
          <P>Breckinridge, Floyd, Grayson, Hancock, Johnson, Knott, Magoffin, Martin, McLean, Meade, Perry, and Wolfe Counties for Public Assistance, including direct Federal assistance.</P>
          <P>Ballard, Daviess, and Henderson Counties for Public Assistance, including direct Federal assistance, (already designated for emergency protective measures [Category B], limited to direct Federal assistance, under the Public Assistance program).</P>
          <P>Crittenden, Hickman, and Livingston Counties for Public Assistance, including direct Federal assistance, (already designated for Individual Assistance and emergency protective measures [Category B], limited to direct Federal assistance, under the Public Assistance program).</P>
          <P>Marshall and Webster Counties for Public Assistance, including direct Federal assistance, (already designated for Individual Assistance).</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13898 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-1974-DR Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Tennessee; Amendment No. 2 to Notice of a Major Disaster Declaration</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This notice amends the notice of a major disaster declaration for the State of Tennessee (FEMA-1974-DR), dated May 1, 2011, and related determinations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 27, 2011.</P>
        </DATES>
        <FURINF>
          <PRTPAGE P="32371"/>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of a major disaster declaration for the State of Tennessee is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 1, 2011.</P>
        
        <EXTRACT>
          <P>Carroll, Crockett, Hardin, Henry, and Madison Counties for Individual Assistance.</P>
          <P>Benton, Carroll, Chester, Crockett, Fayette, Gibson, Hardeman, Hardin, Henderson, Henry, Lake, Madison, McNairy, Shelby, and Weakley for Public Assistance.</P>
          <P>Bradley, Greene, Hamilton and Washington Counties for Public Assistance [Categories C-G] (already designated for Individual Assistance and for debris removal and emergency protective measures [Category A and B], under the Public Assistance program).</P>
          <P>Bledsoe, Cocke, Johnson, McMinn, Monroe, and Rhea Counties for Public Assistance, (already designated for Individual Assistance).</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13914 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-1975-DR; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Arkansas; Amendment No. 4 to Notice of a Major Disaster Declaration</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This notice amends the notice of a major disaster declaration for the State of Arkansas (FEMA-1975-DR), dated May 2, 2011, and related determinations.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 27, 2011.</P>
        </EFFDATE>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of a major disaster declaration for the State of Arkansas is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 2, 2011.</P>
        
        <EXTRACT>
          <P>Arkansas, Lee, Poinsett, and St. Francis Counties for Individual Assistance.</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13915 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-1979-DR; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Tennessee; Amendment No. 1 to Notice of a Major Disaster Declaration</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This notice amends the notice of a major disaster declaration for the State of Tennessee (FEMA-1979-DR), dated May 9, 2011, and related determinations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 26, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of a major disaster declaration for the State of Tennessee is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 9, 2011.</P>
        
        <EXTRACT>
          <P>Gibson and Lauderdale Counties for Individual Assistance (already designated for Public Assistance, including direct Federal assistance.</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13897 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-1982-DR; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Minnesota; Amendment No. 2 to Notice of a Major Disaster Declaration</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This notice amends the notice of a major disaster declaration for the State of Minnesota (FEMA-1982-DR), dated May 10, 2011, and related determinations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date</E>: May 25, 2011.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <PRTPAGE P="32372"/>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>Notice is hereby given that the incident period for this disaster is closed effective May 25, 2011.</P>
        
        <EXTRACT>
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13918 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
        <SUBAGY>Federal Emergency Management Agency</SUBAGY>
        <DEPDOC>[Internal Agency Docket No. FEMA-1982-DR; Docket ID FEMA-2011-0001]</DEPDOC>
        <SUBJECT>Minnesota; Amendment No. 1 to Notice of a Major Disaster Declaration</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Emergency Management Agency, DHS.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This notice amends the notice of a major disaster declaration for the State of Minnesota (FEMA-1982-DR), dated May 10, 2011, and related determinations.</P>
        </SUM>
        <EFFDATE>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">Effective Date:</E>May 24, 2011.</P>
        </EFFDATE>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3886.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of a major disaster declaration for the State of Minnesota is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 10, 2011.</P>
        
        <EXTRACT>
          <P>Becker, Beltrami, Kittson, Marshall, Norman, Otter Tail, Polk, Ramsey, Red Lake, Roseau, Swift, Washington, Wright Counties and the Red Lake Reservation for Public Assistance.</P>
          
          <FP>The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.</FP>
        </EXTRACT>
        <SIG>
          <NAME>W. Craig Fugate,</NAME>
          <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13917 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 9111-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">INTERNATIONAL TRADE COMMISSION</AGENCY>
        <SUBJECT>Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>U.S. International Trade Commission.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled<E T="03">In the Matter of Certain Microprocessors, Components Thereof, and Products Containing Same,</E>DN 2810; the Commission is soliciting comments on any public interest issues raised by the complaint.</P>
        </SUM>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>James R. Holbein, Secretary to the Commission, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at<E T="03">http://edis.usitc.gov,</E>and will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-2000.</P>

          <P>General information concerning the Commission may also be obtained by accessing its Internet server (<E T="03">http://www.usitc.gov</E>). The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at<E T="03">http://edis.usitc.gov.</E>Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The Commission has received a complaint filed on behalf of X2Y Attenuators, LLC (“X2Y”) on May 31, 2011. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain microprocessors, components thereof, and products containing same. The complaint names as respondents Intel Corporation of Santa Clara, CA, Componentes Intel de Costa Rica S.A. of Costa Rica, Intel Malaysia Sdn. Bhd of Malaysia, Intel (Philippines) of the Philippines, Intel Products (Chengdu) Ltd., of People's Republic of China, Intel Product (Shanghai) Ltd. of People's Republic of China, Apple Inc. of Cupertino, CA and Hewlett-Packard Company of Palo Alto, CA.</P>
        <P>The complainant, proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five pages in length, on any public interest issues raised by the complaint. Comments should address whether issuance of an exclusion order and/or a cease and desist order in this investigation would negatively affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.</P>
        <P>In particular, the Commission is interested in comments that:</P>
        <P>(i) Explain how the articles potentially subject to the orders are used in the United States;</P>
        <P>(ii) Identify any public health, safety, or welfare concerns in the United States relating to the potential orders;</P>
        <P>(iii) Indicate the extent to which like or directly competitive articles are produced in the United States or are otherwise available in the United States, with respect to the articles potentially subject to the orders; and</P>
        <P>(iv) Indicate whether Complainant, Complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to an exclusion order and a cease and desist order within a commercially reasonable time.</P>

        <P>Written submissions must be filed no later than by close of business, five business days after the date of publication of this notice in the<E T="04">Federal Register</E>. There will be further<PRTPAGE P="32373"/>opportunities for comment on the public interest after the issuance of any final initial determination in this investigation.</P>

        <P>Persons filing written submissions must file the original document and 12 true copies thereof on or before the deadlines stated above with the Office of the Secretary. Submissions should refer to the docket number (“Docket No. 2810”) in a prominent place on the cover page and/or the first page. The Commission's rules authorize filing submissions with the Secretary by facsimile or electronic means only to the extent permitted by section 201.8 of the rules (see Handbook for Electronic Filing Procedures,<E T="03">http://www.usitc.gov/secretary/fed_reg_notices/rules/documents/handbook_on_electronic_filing.pdf</E>). Persons with questions regarding electronic filing should contact the Secretary (202-205-2000).</P>

        <P>Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.<E T="03">See</E>19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary.</P>
        <P>This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.50(a)(4) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.50(a)(4)).</P>
        <SIG>
          <P>By order of the Commission.</P>
          
          <DATED>Issued: June 1, 2011.</DATED>
          <NAME>James R. Holbein,</NAME>
          <TITLE>Secretary to the Commission.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13889 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 7020-02-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">INTERNATIONAL TRADE COMMISSION</AGENCY>
        <DEPDOC>[Inv. No. 337-TA-774]</DEPDOC>
        <SUBJECT>In the Matter of Certain Electronic Devices Having a Digital Television Receiver and Components Thereof; Notice of Institution of Investigation</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>U.S. International Trade Commission.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Institution of investigation pursuant to 19 U.S.C. 1337.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 29, 2011, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Zenith Electronics LLC of Lincolnshire, Illinois. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain electronic devices having a digital television receiver and components thereof by reason of infringement of certain claims of U.S. Patent No. 5,598,220 (“the `220 patent”); U.S. Patent No. 5,629,958 (“the `958 patent”); and U.S. Patent No. 5,636,251 (“the `251 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.</P>
          <P>The complainant requests that the Commission institute an investigation and, after the investigation, issue an exclusion order and cease and desist order.</P>
        </SUM>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Room 112, Washington, DC 20436, telephone 202-205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at<E T="03">http://www.usitc.gov.</E>The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at<E T="03">http://edis.usitc.gov.</E>
          </P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.</P>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2011).</P>
          </AUTH>
          
          <P>
            <E T="03">Scope of Investigation:</E>Having considered the complaint, the U.S. International Trade Commission, on May 26, 2011,<E T="03">ordered that:</E>
          </P>
          <P>(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain electronic devices having a digital television receiver and components thereof that infringe one or more of claims 65 and 66 of the `220 patent; claims 9-12 of the `958 patent; and claims 1, 2, 4-7, and 10 of the `251 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;</P>
          <P>(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:</P>
          <P>(a) The complainant is:</P>
          
          <FP SOURCE="FP-1">Zenith Electronics LLC, 2000 Millbrook Drive, Lincolnshire, IL 60069.</FP>
          
          <P>(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:</P>
          
          <FP SOURCE="FP-1">Sony Corporation,7-1 Konan 1-Chome,Minato-ku,Tokyo, 108-0075,Japan.</FP>
          <FP SOURCE="FP-1">Sony Corporation of America, 550 Madison Avenue,New York, NY 10022.</FP>
          <FP SOURCE="FP-1">Sony Electronics, Inc.,16530 Via Esprillo,San Diego, CA 92127.</FP>
          
          <P>(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Suite 401, Washington, DC 20436; and</P>
          <P>(3) For the investigation so instituted, the Honorable Paul J. Luckern, Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.</P>
          <P>Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(d)-(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.</P>

          <P>Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the<PRTPAGE P="32374"/>Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.</P>
          <SIG>
            <P>By order of the Commission.</P>
            
            <DATED>Issued: May 31, 2011.</DATED>
            <NAME>James R. Holbein,</NAME>
            <TITLE>Secretary to the Commission.</TITLE>
          </SIG>
        </FURINF>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13854 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 7020-02-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
        <SUBAGY>Occupational Safety and Health Administration</SUBAGY>
        <DEPDOC>[Docket No. OSHA-2011-0065]</DEPDOC>
        <SUBJECT>National Advisory Committee on Occupational Safety and Health (NACOSH)</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Occupational Safety and Health Administration (OSHA), Labor.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Announcement of meetings of the National Advisory Committee on Occupational Safety and Health (NACOSH) and NACOSH subgroups.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The National Advisory Committee on Occupational Safety and Health (NACOSH) will meet June 22, 2011, in Washington, DC. In conjunction with the committee meeting, NACOSH subgroups will meet on June 21, 2011.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>
            <E T="03">NACOSH Meeting:</E>NACOSH will meet from 9 a.m. to 4:30 p.m., Wednesday, June 22, 2011.</P>
          <P>
            <E T="03">NACOSH Subgroup Meetings:</E>The NACOSH subgroups will meet from 11 a.m. to 5 p.m., Tuesday, June 21, 2011.</P>
          <P>
            <E T="03">Submission of Comments, Requests to Speak, Speaker Presentations, and Requests for Special Accommodation:</E>Comments, requests to speak at the NACOSH meeting, speaker presentations, and requests for special accommodations for the NACOSH and NACOSH subgroup meetings must be submitted (postmarked, sent, transmitted) by June 16, 2011.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>
            <E T="03">NACOSH and NACOSH Subgroup Meetings:</E>NACOSH and its subgroups will meet in Room N-N4437 A/B/C/D, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210.</P>
          <P>
            <E T="03">Submission of Comments, Requests to Speak and Speaker Presentations:</E>You must submit comments, requests to speak at the NACOSH meeting and speaker presentations, identified by the docket number for this<E T="04">Federal Register</E>notice (Docket No. OSHA-2011-0065), by one of the following methods:</P>
          <P>
            <E T="03">Electronically:</E>You may submit materials, including attachments, electronically at<E T="03">http://www.regulations.gov,</E>the Federal eRulemaking Portal. Follow the online instructions for making submissions.</P>
          <P>
            <E T="03">Facsimile:</E>If your submission, including attachments, does not exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-1648.</P>
          <P>
            <E T="03">Mail, Express Delivery, Messenger, or Courier Service:</E>You may submit your materials to the OSHA Docket Office, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210, telephone (202) 693-2350 (TTY (887) 889-5627). Deliveries (hand, express mail, messenger, courier service) are accepted during the Department of Labor's and OSHA Docket Office's normal business hours, 8:15 a.m. to 4:45 p.m. E.T.</P>
          <P>
            <E T="03">Requests for Special Accommodation:</E>You may submit requests for special accommodations for the NACOSH and NACOSH subgroup meetings by hard copy, telephone, or e-mail to Ms. Veneta Chatmon, OSHA, Office of Communications, Room N-3647, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-1999; e-mail<E T="03">chatmon.veneta@dol.gov.</E>
          </P>
          <P>
            <E T="03">Instructions:</E>All submissions must include the Agency name and docket number for this<E T="04">Federal Register</E>notice (Docket No. OSHA-2011-0065). Because of security-related procedures, submission by regular mail may result in significant delay in receipt. Please contact the OSHA Docket Office for information about security procedures for making submissions by hand delivery, express delivery, messenger or courier service. For additional information about submitting comments, requests to speak and speaker presentations see the<E T="02">SUPPLEMENTARY INFORMATION</E>section of this notice.</P>
          <P>Comments, requests to speak and speaker presentations, including personal information provided, will be placed in the public docket and may be available online. Therefore, OSHA cautions interested parties about submitting personal information such as social security numbers and birthdates.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>
            <E T="03">For Press Inquiries:</E>Mr. Earl Hicks, OSHA, Office of Communications, U.S. Department of Labor, Room N-3647, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-1999.</P>
          <P>
            <E T="03">For General Information:</E>Ms. Deborah Crawford, OSHA, Directorate of Evaluation and Analysis, U.S. Department of Labor, Room N-3641, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-1932; e-mail<E T="03">crawford.deborah@dol.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">NACOSH Meeting</HD>
        <P>NACOSH will meet Wednesday, June 22, 2011, in Washington, DC. NACOSH meetings are open to the public.</P>
        <P>Section 7(a) of the Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651, 656) authorizes NACOSH to advise the Secretary of Labor and the Secretary of Health and Human Services on matters relating to the administration of the OSH Act. NACOSH is a continuing advisory body and operates in compliance with the OSH Act, the Federal Advisory Committee Act (5 U.S.C. App. 2), and regulations issued pursuant to those laws (29 CFR part 1912a, 41 CFR part 102-3).</P>
        <P>The tentative agenda of the NACOSH meeting includes:</P>
        <P>• Remarks from the Assistant Secretary of Labor for Occupational Safety and Health (OSHA);</P>
        <P>• Remarks from the Director of the National Institute for Occupational Safety and Health;</P>
        <P>• Discussion with NIOSH and OSHA on Chemical Policy;</P>
        <P>• NACOSH subgroup reports;</P>
        <P>• Discussion on injury and illness prevention programs with OSHA staff;</P>
        <P>• Discussion on recordkeeping issues with OSHA staff; and</P>
        <P>• Public comments.</P>
        
        <FP>NACOSH meetings are transcribed and detailed minutes of the meetings are prepared. Meeting transcripts and minutes are included in the public record of the NACOSH meeting.</FP>
        <HD SOURCE="HD1">NACOSH Subgroup Meetings</HD>
        <P>NACOSH established two subgroups, Injury and Illness Prevention Programs and Recordkeeping, at the January 20-21, 2011, NACOSH meeting. Those subgroups will meet from 11 a.m. to 5 p.m., June 21, 2011, in Room N-4437A/B/C and report back to the full committee at the June 22, 2011, NACOSH meeting.</P>
        <HD SOURCE="HD1">Public Participation</HD>
        <P>
          <E T="03">NACOSH and NACOSH subgroup meetings:</E>NACOSH and NACOSH subgroup meetings are open to the public. Any individual attending meetings at the U.S. Department of Labor must enter the building at the<PRTPAGE P="32375"/>Visitors' Entrance, at 3rd and C Streets, NW., and pass through Building Security. Attendees must have valid government-issued photo identification to enter the building. Please contact Ms. Crawford for additional information about building security measures for attending the NACOSH and NACOSH subgroup meetings.</P>
        <P>Individuals needing special accommodations to attend NACOSH and NACOSH subgroup meetings should contact Ms. Chatmon.</P>
        <P>
          <E T="03">Submission of Written Comments, Requests to Speak and Speaker Presentations:</E>Interested parties may submit written comments, requests to speak at the NACOSH meeting and speaker presentations by June 16, 2011, using one of the methods listed in the<E T="02">ADDRESSES</E>section. All submissions must include the Agency name and docket number for this<E T="04">Federal Register</E>notice (Docket No. OSHA-2011-0065). OSHA will provide submissions to NACOSH members prior to the meeting.</P>

        <P>Requests to speak must state the amount of time requested to speak, the interest the individual represents (<E T="03">e.g.,</E>organization name), if any, and a brief outline of the presentation. Electronic speaker presentations (<E T="03">e.g.,</E>PowerPoint) must be compatible with PowerPoint 2003 and other Microsoft 2003 formats. Requests to address NACOSH may be granted as time permits and at the discretion of the NACOSH chair.</P>
        <P>Because of security-related procedures, submission by regular mail may result in significant delay in receipt. Please contact the OSHA Docket Office for information about security procedures for making submissions by hand delivery, express delivery, messenger or courier service.</P>
        <P>
          <E T="03">Public Docket of the NACOSH Meeting:</E>Comments, requests to speak and speaker presentations, including any personal information you provide, are placed in the public docket of this NACOSH meeting without change and may be available online at<E T="03">http://www.regulations.gov.</E>Therefore, OSHA cautions you about submitting certain personal information such as social security numbers and birthdates.</P>

        <P>Meeting transcripts and minutes, subgroup reports and other documents from the NACOSH meeting also are included in the public record of the NACOSH meeting. Although all submissions are listed in the<E T="03">http://www.regulations.gov</E>index, some documents (<E T="03">e.g.,</E>copyrighted materials) are not publicly available to read or download through that webpage. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office.</P>

        <P>To read or download documents in the public docket of this NACOSH meeting go to Docket No. OSHA-2011-0065 at<E T="03">http://www.regulations.gov.</E>For information on using<E T="03">http://www.regulations.gov</E>to access the docket, click on the “Help” tab at the top of the Home page. Contact the OSHA Docket Office for information about materials not available through that webpage and for assistance in using the Internet to locate submissions and other documents in the public docket.</P>
        <P>Electronic copies of this<E T="04">Federal Register</E>notice are available at<E T="03">http://www.regulations.gov.</E>This notice, as well as news releases and other relevant information, is also available on the OSHA webpage at<E T="03">http://www.osha.gov.</E>
        </P>
        <HD SOURCE="HD1">Authority and Signature</HD>
        <P>David Michaels, PhD, MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice under the authority granted by Section 7 of the Occupational Safety and Health Act of 1970 (U.S.C. 656), the Federal Advisory Committee Act (5 U.S.C. App. 2); 29 CFR part 1912a; 41 CFR part 102-3; and Secretary of Labor's Order No. 4-2010 (75 FR 55355, 9/10/2010).</P>
        <SIG>
          <P>Signed at Washington, DC, on June 1, 2011.</P>
          <NAME>David Michaels,</NAME>
          <TITLE>Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13901 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4510-26-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">OFFICE OF MANAGEMENT AND BUDGET</AGENCY>
        <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request; The Partnership Fund for Program Integrity Innovation Pilot Idea Template</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Office of Management and Budget.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for public comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>The Office of Federal Financial Management (OFFM) within OMB is proposing for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501<E T="03">et seq.</E>) the following template for pilot idea summaries submitted to the Partnership Fund for Program Integrity Innovation (Partnership Fund). This notice announces that OFFM intends to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed collection.</P>
          <P>The Partnership Fund seeks to identify pilot projects to improve the service delivery, payment accuracy, and administrative efficiency of state-administered Federal assistance programs, while also reducing access barriers for eligible beneficiaries.</P>

          <P>The proposed pilot idea summary template is intended for use by those wishing to submit pilot ideas for consideration. It outlines the specific information required by the Partnership Fund to make informed decisions in the pilot selection process. Pilot ideas to advance the Partnership Fund's goals are being solicited from all stakeholders, including the general public. The template is currently in use by Federal agencies based on OMB guidance. If approved under the Paperwork Reduction Act, it will be used to solicit ideas from stakeholders outside the Federal government both as a general template and as an online form for idea solicitations through the Partnership Fund Web site,<E T="03">http://www.partner4solutions.gov.</E>Currently, general ideas may be submitted via e-mail to<E T="03">partner4solutions@omb.eop.gov,</E>or through<E T="03">http://www.partner4solutions.gov.</E>The Partnership Fund is funded through FY 2012 and will continue to accept pilot idea proposals on a rolling basis until funding is exhausted. The Partnership Fund must comply with a statutory requirement that all pilot projects, when taken together, be cost neutral.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>All comments on the pilot idea summary template must be in writing and received by August 5, 2011. Following review and disposition of public comments on this 60-day notice, OFFM will submit comments to OMB for review and issue its own 30-day notice to solicit additional public comments.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, we encourage respondents to submit comments electronically to ensure timely receipt. We cannot guarantee that comments mailed will be received before the comment closing date.</P>
          <P>Comments may be e-mailed to:<E T="03">mmassey@omb.eop.gov.</E>Please include the full body of your comments in the text of the electronic message, as well as in an attachment. Please include your name, title, organization, postal address, telephone number, and e-mail address in the text of the message. Comments may also be submitted via facsimile to (202) 395-3242.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Please visit our Web site at<E T="03">http://www.partner4solutions.gov</E>or contact Meg Massey at (202) 395-7552 or<E T="03">mmassey@omb.eop.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <PRTPAGE P="32376"/>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">Background</HD>
        <P>The Partnership Fund for Program Integrity Innovation (Partnership Fund) was established by the Consolidated Appropriations Act of 2010 (Pub. L. 111-117). An appropriation of $32.5 million<SU>1</SU>
          <FTREF/>provides money to pilot and evaluate promising innovations that confront these challenges in Federal, State and/or local administration. The purpose of the Partnership Fund is to identify and evaluate innovations in programs jointly administered by Federal and State agencies and in other program areas where Federal-state cooperation would be beneficial. OMB coordinates and manages the Partnership Fund for the purpose of conducting pilot projects that test these innovations. The pilots will emphasize the Partnership Fund's four goals: service delivery, program integrity, administrative efficiency, and program access.</P>
        <FTNT>
          <P>
            <SU>1</SU>The initial FY 2010 appropriation for the Partnership Fund was for $37.5 million. This appropriation has been reduced to $32.5 million due to a $5 million rescission in Public Law 112-10.</P>
        </FTNT>

        <P>Ideas submitted by the public are shared with the Collaborative Forum, a self-directed stakeholder group (<E T="03">http://www.collaborativeforumonline.com)</E>established to fulfill the statutory requirement that the OMB Director consult with an “interagency council of stakeholders” in determining which pilots will receive Partnership Fund funding. The Collaborative Forum identifies pilot ideas that show the greatest potential for meeting the Partnership Fund's four goals and convenes work groups to further develop these ideas into feasible, measurable pilot concepts. Collaborative Forum work groups include state and other stakeholders with relevant expertise. Work groups produce pilot concept papers describing the goals, methods, resource requirements, and anticipated outcomes of proposed pilots. Ideas sent to the Collaborative Forum may be developed into pilot concept papers to send to OMB for funding consideration.</P>
        <P>Federal agencies may also develop ideas into pilot concept papers that are shared with the Collaborative Forum for consultation. Pilot concepts are then submitted for funding approval by OMB, which takes into account the consultation provided by the Collaborative Forum and by the Partnership Fund's Federal Steering Committee, which consists of senior policy officials from Federal agencies that administer the major benefits programs.</P>
        <P>Funds for each approved pilot concept are transferred to a lead Federal agency, which in turn selects specific states, localities, and/or other relevant entities to participate in the pilot by implementing specific pilot projects using pilot funds. The lead agency also conducts a cost-effective evaluation of the pilot projects. Based on evaluation findings, successful pilots will serve as models for other states and local agencies. Evaluation results may also be used to inform future administrative or legislative changes to the affected programs, including broader implementation of the innovations tested.</P>
        <P>
          <E T="03">Examples of Programs and Pilots:</E>Examples of Federally funded, state-administered assistance programs relevant to the goals of the Partnership Fund are listed below. Other programs will also be included in concept idea submissions.</P>
        <P>• Special Supplemental Nutrition Program for Women, Infants and Children (WIC).</P>
        <P>• Supplemental Nutrition Assistance Program (SNAP—formerly Food Stamps).</P>
        <P>• Medicaid.</P>
        <P>• Unemployment Insurance (UI).</P>
        <P>• Child Welfare.</P>
        <P>• Child Care.</P>
        <P>• Temporary Assistance for Needy Families (TANF).</P>
        <P>Examples of the types of pilots that could be supported include:</P>
        <P>• Pilots that simplify or streamline processes for application, eligibility determination, and confirmation of continued eligibility</P>
        <P>• Pilots that promote or utilize data matching and information sharing across programs</P>
        <P>• Pilots that test integrated applications, screening, and verification for multiple benefit programs</P>
        <P>Components of an ideal pilot are listed below. Not every pilot concept considered for funding will meet all of these criteria, and the size and scope of the pilot projects funded may vary widely:</P>
        <P>• Yield reliable data that can be captured in the pilot evaluation to suggest replication or expansion and demonstrate how successfully the pilot meets the Partnership Fund's four goals</P>
        <P>• Have the potential to be replicated and sustained on a larger scale</P>
        <P>• Address multiple elements of the Partnership Fund's four goals</P>
        <P>• Address multiple programs and/or otherwise bridge organizational silos</P>
        <P>• Yield measurable results in nine to 18 months</P>
        <P>• Support the statutory requirement that Partnership Fund pilot projects be cost neutral when looked at as a whole</P>
        <P>
          <E T="03">Current Actions:</E>New collection of information.</P>
        <P>
          <E T="03">Type of Review:</E>New Collection.</P>
        <P>
          <E T="03">Affected Public:</E>Individuals and Households, Businesses and Organizations, State, Local, or Tribal Government.</P>
        <P>
          <E T="03">Estimated Number of Respondents:</E>300.</P>
        <P>
          <E T="03">Frequency of Response:</E>We expect that most respondents will use the form to submit one idea, while some respondents may submit more than one idea.</P>
        <P>
          <E T="03">Average minutes per response:</E>2 hours.</P>
        <P>
          <E T="03">Burden Hours:</E>600.</P>
        <P>
          <E T="03">Needs and Uses:</E>The template is currently being used by Federal agencies, per OMB guidance, to submit pilot ideas to the Partnership Fund for Program Integrity Innovation, and as a useful reference for other organizations or individuals wishing to submit pilot ideas. If approved, the template will be made available for use by all agencies, individuals, and organizations wishing to submit pilot concept proposals for consideration.</P>
        <P>
          <E T="03">Obligation to respond:</E>Voluntary. However, if Federal agencies wish to pursue a pilot through the Partnership Fund, they should use this template.</P>
        <P>
          <E T="03">Nature and extent of confidentiality:</E>All pilot ideas submitted to the Partnership Fund may be posted on the Collaborative Forum Web site,<E T="03">http://www.collaborativeforumonline.com,</E>for comment and feedback. Individuals and organizations that submit ideas, regardless of whether they elect to use the template, may submit contact information if they wish to be contacted by the Collaborative Forum about their idea. Contact information, if submitted, will not be shared or used for any other purpose.</P>
        <P>
          <E T="03">Privacy Impact Assessment:</E>All ideas submitted to the Partnership Fund may be posted on the Collaborative Forum Web site for comment and feedback. The template makes clear that the ideas submitted will be shared.</P>
        <P>
          <E T="03">Requests for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity<PRTPAGE P="32377"/>of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.</P>
        <P>All written comments will be available for public inspection on Regulations.gov.</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.</P>
        <SIG>
          <DATED>Debra J. Bond,</DATED>
          <TITLE>Deputy Controller.</TITLE>
        </SIG>
        <HD SOURCE="HD1">PARTNERSHIP FUND FOR PROGRAM INTEGRITY INNOVATION TEMPLATE INSTRUCTIONS FOR PILOT IDEA SUMMARY</HD>

        <P>The first step in the Partnership Fund pilot selection process is the submission of a pilot idea summary. Pilot idea summaries may be submitted by anyone through the partner4solutions.gov Web site,<E T="03">www.partner4solutions.gov,</E>or the<E T="03">partner4solutions@omb.eop.gov</E>email address. Pilot ideas may be sent to an independent Collaborative Forum for further development into more detailed concept papers. OMB consults with the Federal Steering Committee in selecting pilot concepts and making funding decisions.</P>
        <P>Below are instructions for completing a pilot idea summary. Completed pilot idea summaries should not be more than two pages in length.</P>

        <HD SOURCE="HD1">PARTNERSHIP FUND FOR PROGRAM INTEGRITY INNOVATION PILOT IDEA:<E T="03">Name of Pilot Idea</E>
        </HD>
        <P>
          <E T="04">1. Pilot Idea:</E>
          <E T="03">Summarize the idea in 2-3 sentences.</E>
        </P>
        <P>
          <E T="04">2. Programs Affected:</E>
        </P>
        <P>•<E T="03">Which programs are affected, either directly or indirectly? Ideally, an idea would address multiple programs and bridge multiple programmatic silos</E>.</P>
        <P>•<E T="03">Are these federal, state, and/or local programs? An ideal submission would involved multiple states and/or communities in the development or eventual implementation of a pilot.</E>
        </P>
        <P>
          <E T="04">3. Measurable Impacts:</E>
          <E T="03">How does the pilot impact each of the four goals of the Partnership Fund? A pilot should address as many of these goals as possible across multiple programs or test a solution that could later be applied to multiple programs.</E>
        </P>
        <P>
          <E T="7462">a) Improving payment accuracy</E>
        </P>
        <P>
          <E T="7462">b) Improving administrative efficiency</E>
        </P>
        <P>
          <E T="7462">c) Improving service delivery</E>
        </P>
        <P>
          <E T="7462">d) Reducing access barriers for eligible beneficiaries</E>
        </P>
        <P>
          <E T="04">4. Expected Outcomes and Measurement Methodologies:</E>
        </P>
        <P>•<E T="03">What are the expectations and measures of success in relation to the four goals?</E>
        </P>
        <P>•<E T="03">What are the possible quantitative and qualitative measures?</E>
        </P>
        <P>•<E T="03">Could these outcomes be extrapolated to a larger environment?</E>
        </P>
        <P>
          <E T="04">5. Potential Partners or Sponsors:</E>
        </P>
        <P>•<E T="03">Which stakeholders and/or key organizations are involved?</E>
        </P>
        <P>•<E T="03">Does the proposed pilot have sufficient stakeholder buy-in? Stakeholders could include federal, state, and local governments, and non-governmental organizations.</E>
        </P>
        <P>
          <E T="04">6. Estimated Operating Cost of Pilot:</E>
        </P>
        <P>•<E T="03">How much would the pilot cost to implement?</E>
        </P>
        <P>•<E T="03">Are there resources of matching or leveraged funds that could be used to support this pilot?</E>
        </P>
        <P>•<E T="03">Is the Partnership Fund the most appropriate funding source for the pilot? All pilot ideas will be considered, but the Partnership Fund is targeting ideas that attempt to cut across multiple programs with multiple objectives, but have struggled to gain footing in existing program silos.</E>
        </P>
        <P>
          <E T="04">7. Estimated Impact on Program Costs:</E>
        </P>
        <P>•<E T="03">What are the anticipated costs and/or savings for the various programs involved in the pilot?</E>
        </P>
        <P>•<E T="03">If the pilot were to be scaled up, what are the anticipated costs/savings? Pilot ideas that increase program costs will be considered, but the Partnership Fund must comply with our statutory requirement to maintain overall cost neutrality.</E>
        </P>
        <P>
          <E T="04">8. Pilot Implementation Issues:</E>
        </P>
        <P>•<E T="03">Is this pilot idea ready for immediate implementation, or does it require further refinement?</E>
        </P>
        <P>•<E T="03">What is the timeframe in which the pilot would be conducted? The target time period for conducting the first round of pilots is 9-18 months.</E>
        </P>
        <P>•<E T="03">What are possible implementation barriers (e.g., privacy issues)?</E>
        </P>
        <P>•<E T="03">Is this pilot scalable? Successful ideas will demonstrate strong external validity and scalability.</E>
        </P>
        <P>•<E T="03">Could this pilot be implemented under existing legislative authorities or mechanisms?</E>
        </P>
        <P>•<E T="03">Are any administrative waivers required?</E>
        </P>
        <HD SOURCE="HD1">PARTNERSHIP FUND FOR PROGRAM INTEGRITY INNOVATION</HD>
        <HD SOURCE="HD1">PILOT IDEA SUMMARY:<E T="03">Name of Pilot Idea</E>
        </HD>
        <P>
          <E T="04">1. Pilot Idea:</E>
        </P>
        <P>
          <E T="04">2. Programs Affected:</E>
        </P>
        <P>
          <E T="04">3. Measurable Impacts:</E>
        </P>
        <P>
          <E T="7462">a) Improving payment accuracy</E>
        </P>
        <P>
          <E T="7462">b) Improving administrative efficiency</E>
        </P>
        <P>
          <E T="7462">c) Improving service delivery</E>
        </P>
        <P>
          <E T="7462">d) Reducing access barriers for beneficiaries</E>
        </P>
        <P>
          <E T="04">4. Expected Outcomes and Measurement Methodologies:</E>
        </P>
        <P>
          <E T="04">5. Potential Partners or Sponsors:</E>
        </P>
        <P>
          <E T="04">6. Estimated Operating Cost of Pilot:</E>
        </P>
        <P>
          <E T="04">7. Estimated Impact on Program Costs:</E>
        </P>
        <P>
          <E T="04">8. Pilot Implementation Issues:</E>
        </P>
        
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13892 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 3110-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">OFFICE OF MANAGEMENT AND BUDGET</AGENCY>
        <SUBJECT>Audits of States, Local Governments, and Non-Profit Organizations; OMB Circular A-133 Compliance Supplement</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Executive Office of the President, Office of Management and Budget.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of availability of the 2011 OMB Circular A-133 Compliance Supplement.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>This notice announces the availability of the 2011 OMB Circular A-133 Compliance Supplement (Supplement). The notice also offers interested parties an opportunity to comment on the 2011 Supplement. The 2011 Supplement adds nineteen new programs, including five programs added to existing clusters. It deletes two programs and has also been updated for program changes and technical corrections. The two deleted programs are Catalog of Federal Domestic Assistance (CFDA) 84.037, Reading First State Grants, and CFDA 84.938,<PRTPAGE P="32378"/>Hurricane Education Recovery, which are no longer active (<E T="03">i.e.,</E>no funds are being spent by recipients), and have been archived in the CFDA.</P>

          <P>In total, the 2011 Supplement includes 248 individual programs. A list of changes to the 2011 Supplement can be found at Appendix V. It updates Appendix VII that provides an audit alert and compliance requirements regarding the grant programs funded under American Recovery and Reinvestment Act of 2009. Due to its length, the 2011 Supplement is not included in this Notice. See<E T="02">ADDRESSES</E>for information about how to obtain a copy either on line or through the Government Printing Office.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>The 2011 Supplement will apply to audits of fiscal years beginning after June 30, 2010 and supersedes the 2010 Supplement. All comments on the 2011 Supplement must be in writing and received by October 31, 2011. Late comments will be considered to the extent practicable. We received no comments on the 2010 Supplement.</P>
          <P>Due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, we encourage respondents to submit comments electronically to ensure timely receipt. We cannot guarantee that comments mailed will be received before the comment closing date.</P>
          <P>Electronic mail comments may be submitted to:<E T="03">Hai_M._Tran@omb.eop.gov.</E>Please include “A-133 Compliance Supplement—2011” in the subject line and the full body of your comments in the text of the electronic message and as an attachment. Please include your name, title, organization, postal address, telephone number, and e-mail address in the text of the message. Comments may also be submitted via facsimile at 202-395-3952.</P>
          <P>Comments may be mailed to Gilbert Tran, Office of Federal Financial Management, Office of Management and Budget, 725 17th Street, NW., Room 6025, New Executive Office Building, Washington, DC 20503.</P>
          <P>Comments may also be sent to via<E T="03">http://www.regulations.gov</E>—a Federal E-Government Web site that allows the public to find, review, and submit comments on documents that agencies have published in the<E T="04">Federal Register</E>and that are open for comment. Simply type “A-133 Compliance Supplement—2011” (in quotes) in the Comment or Submission search box, click Go, and follow the instructions for submitting comments. Comments received by the date specified above will be included as part of the official record.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>

          <P>The 2011 Supplement is available on-line under the Management heading from the OMB home page (Management/Grants Management/Circulars subpage) on the Internet at<E T="03">http://www.whitehouse.gov/omb.</E>Hard copies of the 2011 Supplement may be purchased at any Government Printing Office (GPO) bookstore (stock number: 041-001-00687-7). The main GPO bookstore is located at 710 North Capitol Street, NW., Washington, DC 20401, (202) 512-0132.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Recipients should contact their cognizant or oversight agency for audit, or Federal awarding agency, as appropriate under the circumstances. The Federal agency contacts are listed in Appendix III of the Supplement. Subrecipients should contact their pass-through entity. Federal agencies should contact Gilbert Tran, Office of Management and Budget, Office of Federal Financial Management, at (202) 395-3052.</P>
          <SIG>
            <NAME>Debra J. Bond,</NAME>
            <TITLE>Deputy Controller.</TITLE>
          </SIG>
        </FURINF>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13893 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">NATIONAL SCIENCE FOUNDATION</AGENCY>
        <SUBJECT>Notice of Intent To Seek Approval To Establish an Information Collection</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>National Science Foundation.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and Request for Comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Science Foundation (NSF) will publish periodic summaries of proposed projects.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments on this notice must be received by August 5, 2011 to be assured of consideration. Comments received after that date will be considered to the extent practicable.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR ADDITIONAL INFORMATION OR COMMENTS:</HD>

          <P>Contact Suzanne Plimpton, Acting Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 295, Arlington, Virginia 22230; telephone 703-292-7556; or send e-mail to<E T="03">splimpto@nsf.gov</E>. Individuals who use telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. to 8 p.m., Eastern Time, Monday through Friday. You also may obtain a copy of the data collection instrument and instructions from Suzanne Plimpton.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P SOURCE="NPAR">
          <E T="03">Title of Collection:</E>National Evaluation of the Alliances for Graduate Education and the Professoriate, program survey and interview and focus group protocols.</P>
        <P>
          <E T="03">OMB Approval Number:</E>3145-New.</P>
        <P>
          <E T="03">Expiration Date of Approval:</E>Not applicable.</P>
        <P>
          <E T="03">Type of Request:</E>Intent to seek approval to establish an information collection for three years.</P>
        <P>
          <E T="03">Proposed Project:</E>The Division of Human Resource Development of the Education and Human Resources Directorate (EHR/HRD) of the National Science Foundation has requested information on the Alliances for Graduate Education and the Professoriate (AGEP) Program. Funded by NSF, the AGEP Program currently funds 17 alliances of postsecondary institutions to promote the participation of underrepresented minority students in PhD programs in the fields of science, technology, engineering and mathematics (STEM). The ultimate goal of the program is to increase the number of underrepresented minorities in these fields who enter the professoriate. NSF seeks information from participants—that is, staff, students and faculty—to determine what influence the program has had on minority graduate students' decisions to enroll in and graduate from STEM doctoral programs and enter the professoriate. NSF proposes a longitudinal approach to the evaluation that includes analysis of extant data sources (<E T="03">e.g.,</E>Survey of Earned Doctorates), virtual site visits with AGEP institutions, and a program survey. The virtual site visits will include up to 30 PhD granting universities (up to 10 each year in 2011, 2012, and 2013). These site visits include interviews with program staff and focus groups with students and faculty via videoconferencing or phone. The program survey will be completed once by each AGEP-funded institution.</P>
        <P>
          <E T="03">Estimate of Burden for Virtual Site Visits:</E>The Foundation estimates that, on average, 90 minutes will be required to conduct each program staff interview (2 per institution) and 60 minutes will be required for each faculty or student focus group (6 participants per group per institution). The Foundation estimates a total of up to 90 (1.5 hr × 2 × 30) hours to complete all program staff interviews and up to 360 (1hr × 12 × 30) hours to complete all faculty and student focus groups bringing the total burden hours to 450 for all respondents. Visited institutions will be selected<PRTPAGE P="32379"/>based on characteristics (<E T="03">e.g.,</E>institution type, student population served, age of alliance, geography) that will allow for a variety of perspectives.</P>
        <P>
          <E T="03">Respondents (Virtual Site Visits):</E>AGEP STEM program staff at 30 AGEP STEM institutions; STEM faculty at 30 AGEP STEM institutions and STEM graduate students at 30 AGEP institutions.</P>
        <P>
          <E T="03">Estimated Total Number of Respondents (Virtual Site Visits):</E>420 individuals total.</P>
        <P>
          <E T="03">Estimated Total Annual Burden on Respondents:</E>150 hrs annually.</P>
        <P>
          <E T="03">Estimate of Burden for Program Survey:</E>The Foundation estimates that, on average, 30 minutes will be required to administer a 65 question survey to a program coordinator at each AGEP STEM funded PhD institution. The survey will be administered once to all institutions funded as of May 2013. Respondents from the up to 82 institutions that received NSF AGEP support will be asked to complete this survey once.</P>
        <P>
          <E T="03">Respondents (Surveys):</E>One AGEP STEM program staff member at up to 82 AGEP STEM institutions.</P>
        <P>
          <E T="03">Estimated Total Number of Responses (Surveys):</E>5,330.</P>
        <P>
          <E T="03">Estimated Total Annual Burden on Respondents:</E>25 hours in year one for each of the 50 surveys; 8 hours in year two and 8 hours in year three for estimated grantees after spring 2011.</P>
        <SIG>
          <DATED>Dated: June 1, 2011.</DATED>
          <NAME>Suzanne H. Plimpton,</NAME>
          <TITLE>Reports Clearance Officer, National Science Foundation.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13904 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 7555-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION</AGENCY>
        <DEPDOC>[Docket No. NRC-2011-0099]</DEPDOC>
        <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Nuclear Regulatory Commission (NRC).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>The NRC invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the<E T="04">Federal Register</E>under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).</P>
          <P>Information pertaining to the requirement to be submitted:</P>
          <P>1.<E T="03">The title of the information collection:</E>NRC Form 354, “Data Report on Spouse.”</P>
          <P>2.<E T="03">Current OMB approval number:</E>OMB 3150-0026.</P>
          <P>3.<E T="03">How often the collection is required:</E>On Occasion.</P>
          <P>4.<E T="03">Who is required or asked to report: NRC contractors, licensees, applicants, and other (e.g. intervenor's) who marry or cohabitate after completing the Personnel Security Forms, or after having been granted an NRC access authorization or employment clearance.</E>
          </P>
          <P>5.<E T="03">The number of annual respondents:</E>80.</P>
          <P>6.<E T="03">The number of hours needed annually to complete the requirement or request:</E>16 hours.</P>
          <P>7.<E T="03">Abstract:</E>NRC Form 354 must be completed by NRC contractors, licensees, applicants who marry or cohabitate after completing the Personnel Security Forms, or after having been granted an NRC access authorization or employment clearance. Form 354 identifies the respondent, the marriage, and data on the spouse and spouse's parents. This information permits the NRC to make initial security determinations and to assure there is no increased risk to the common defense and security.</P>
          <P>Submit, by August 5, 2011, comments that address the following questions:</P>
          <P>1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?</P>
          <P>2. Is the burden estimate accurate?</P>
          <P>3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?</P>
          <P>4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?</P>

          <P>The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site:<E T="03">http://www.nrc.gov/public-involve/doc-comment/omb/index.html.</E>
          </P>
          <P>The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2011-0099. You may submit your comments by any of the following methods:</P>
          <P>
            <E T="03">Electronic comments:</E>Go to<E T="03">http://www.regulations.gov</E>and search for Docket No. NRC-2011-0099. Mail comments to NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at 301-415-6258, or by e-mail to<E T="03">INFOCOLLECTS.Resource@NRC.GOV.</E>
          </P>
        </SUM>
        <SIG>
          <DATED>Dated at Rockville, Maryland, this 27th day of May, 2011.</DATED>
          
          <P>For the Nuclear Regulatory Commission.</P>
          <NAME>Tremaine Donnell,</NAME>
          <TITLE>NRC Clearance Officer, Office of Information Services.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13852 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 7590-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">NUCLEAR REGULATORY COMMISSION</AGENCY>
        <DEPDOC>[Docket No. NRC-2011-0114]</DEPDOC>
        <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Nuclear Regulatory Commission (NRC).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>The NRC invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the<E T="04">Federal Register</E>under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).</P>
          <P>Information pertaining to the requirement to be submitted:</P>
          <P>1.<E T="03">The title of the information collection:</E>10 CFR Part 61—Licensing Requirements for Land Disposal of Radioactive Waste.</P>
          <P>2.<E T="03">Current OMB approval number:</E>3150-0135.</P>
          <P>3.<E T="03">How often the collection is required:</E>Applications for licenses are<PRTPAGE P="32380"/>submitted as needed. Other reports are submitted annually and as other events require.</P>
          <P>4.<E T="03">Who is required or asked to report:</E>Applicants for and holders of an NRC license (to include Agreement State licensees) for land disposal of low-level radioactive waste; and all generators, collectors, and processors of low-level waste intended for disposal at a low-level waste facility.</P>
          <P>5.<E T="03">The number of annual respondents:</E>4.</P>
          <P>6.<E T="03">The number of hours needed annually to complete the requirement or request:</E>5,412 hours (56 hours for reporting [approximately 4.6 hours per response] and 5,356 hours for recordkeeping [approximately 1,339 hours per recordkeeper]).</P>
          <P>7.<E T="03">Abstract:</E>10 CFR part 61 establishes the procedures, criteria, and license terms and conditions for the land disposal of low-level radioactive waste. The reporting and recordkeeping requirements are mandatory and, in the case of application submittals, are required to obtain a benefit. The information collected in the applications, reports, and records is evaluated by the NRC to ensure that the licensee's or applicant's disposal facility, equipment, organization, training, experience, procedures, and plans provide an adequate level of protection of public health and safety, common defense and security, and the environment.</P>
          <P>Submit, by August 5, 2011, comments that address the following questions:</P>
          <P>1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?</P>
          <P>2. Is the burden estimate accurate?</P>
          <P>3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?</P>
          <P>4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?</P>

          <P>The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852 OMB clearance requests are available at the NRC's Web site:<E T="03">http://www.nrc.gov/public-involve/doc-comment/omb/index.html.</E>The documents will be available on the NRC home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2011-0114. You may submit your comments by any of the following methods. Electronic comments: Go to<E T="03">http://www.regulations.gov</E>and search for Docket No. NRC-2011-0114. Mail comments to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at 301-415-6258, or by e-mail to<E T="03">INFOCOLLECTS.Resource@NRC.GOV.</E>
          </P>
        </SUM>
        <SIG>
          <DATED>Dated at Rockville, Maryland, this 27th day of May, 2011.</DATED>
          
          <P>For the Nuclear Regulatory Commission.</P>
          <NAME>Tremaine Donnell,</NAME>
          <TITLE>NRC Clearance Officer, Office of Information Services.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13853 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 7590-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
        <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
        <FP SOURCE="FP-1">Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of Investor Education and Advocacy, Washington, DC 20549-0213.</FP>
        
        <EXTRACT>
          <FP SOURCE="FP-2">Extension:</FP>
          <FP SOURCE="FP1-2">Rule 17Ac3-1(a) and SEC File No. 270-96; OMB Control No. 3235-0151; Form TA-W (1669).</FP>
        </EXTRACT>
        

        <P>Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501<E T="03">et seq.</E>), the Securities and Exchange Commission (“Commission”) has submitted to the Office of Management and Budget requests for approval of extension on the following rule and form: Rule 17Ac3-1(a) (17 CFR 240.17Ac3-1(a)) and Form TA-W (17 CFR 249b.101) under the Securities Exchange Act of 1934 (15 U.S.C. 78a<E T="03">et seq.</E>).</P>

        <P>Section 17A(c)(4)(B) of the Securities Exchange Act of 1934 (15 U.S.C. 78a<E T="03">et seq.</E>) authorizes transfer agents registered with an appropriate regulatory agency (“ARA”) to withdraw from registration by filing with the ARA a written notice of withdrawal and by agreeing to such terms and conditions as the ARA deems necessary or appropriate in the public interest, for the protection of investors, or in the furtherance of the purposes of Section 17A.</P>
        <P>In order to implement Section 17A(c)(4)(B) of the Exchange Act the Commission, on September 1, 1977, promulgated Rule 17Ac3-1(a) and accompanying Form TA-W. On January 11, 2007, the Commission amended Rule 17Ac3-1(a) and accompanying Form TA-W to require that the form be filed in electronic format through EDGAR. Rule 17Ac3-1(a) provides that notice of withdrawal of registration as a transfer agent with the Commission shall be filed on Form TA-W. Form TA-W requires the withdrawing transfer agent to provide the Commission with certain information, including: (1) The locations where transfer agent activities are or were performed; (2) the reasons for ceasing the performance of such activities; (3) disclosure of unsatisfied judgments or liens; and (4) information regarding successor transfer agents.</P>
        <P>The Commission uses the information disclosed on Form TA-W to determine whether the registered transfer agent applying for withdrawal from registration as a transfer agent should be allowed to deregister and, if so, whether the Commission should attach to the granting of the application any terms or conditions necessary or appropriate in the public interest, for the protection of investors, or in furtherance of the purposes of Section 17A of the Exchange Act. Without Rule 17Ac3-1(a) and Form TA-W, transfer agents registered with the Commission would not have a means to voluntarily deregister when necessary or appropriate to do so.</P>

        <P>Respondents file approximately 50 TA-Ws with the Commission annually. A Form TA-W filing occurs only once, when a transfer agent is seeking deregistration. Respondents file approximately 50 TA-Ws with the Commission annually. A Form TA-W filing occurs only once, when a transfer agent is seeing deregistration. Approximately 80 percent of Form TA-Ws are completed by the transfer agent or its employees and approximately 20 percent of Forms TA-W are completed by an outside filing agent that is hired by the registrant to prepare the form and file it electronically. In view of the readily-available information requested by Form TA-W, its short and simple presentation, and the Commission's experience with the filers, we estimate that approximately 30 minutes is required to complete and file Form TA-W, which consists primarily of external<PRTPAGE P="32381"/>labor costs plus a nominal and unquantifiable amount of computer operations/maintenance cost (because the Forms must be filed electronically through the Commission's EDGAR system). For transfer agents that complete Form TA-W themselves, we estimate the cost per filing is $25 (.5 hours times $50 average hourly rate for clerical staff time), which is an internal labor cost. We estimate that outside filing agents charge $100 to complete and file at TA-W on behalf of a registrant, reflecting an external cost to respondents.</P>
        <P>The Commission may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.</P>

        <P>Background documentation for this information collection may be viewed at the following link,<E T="03">http://www.reginfo.gov.</E>Comments should be directed to: (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503, or by sending an e-mail to:<E T="03">Shagufta_Ahmed@omb.eop.gov;</E>and (ii) Thomas Bayer, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312, or send an e-mail to:<E T="03">PRA_Mailbox@sec.gov.</E>Comments must be submitted to OMB within 30 days of this notice.</P>
        <SIG>
          <DATED>May 31, 2011.</DATED>
          <NAME>Cathy H. Ahn,</NAME>
          <TITLE>Deputy Secretary.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13857 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8011-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
        <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
        <FP SOURCE="FP-1">
          <E T="03">Upon Written Request, Copies Available From:</E>Securities and Exchange Commission, Office of Investor Education and Advocacy, Washington, DC 20549-0213.</FP>
        
        <FP SOURCE="FP-2">
          <E T="03">Extension:</E>
        </FP>
        <FP SOURCE="FP1-2">Rule 15c2-11; SEC File No. 270-196; OMB Control No. 3235-0202. .</FP>
        

        <P>Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501<E T="03">et seq.</E>), the Securities and Exchange Commission (Commission) has submitted to the Office of Management and Budget a request for approval of extension of the previously approved collection of information provided for in Rule 15c2-11, (17 CFR 240.15c2-11), under the Securities Exchange Act of 1934 (15 U.S.C. 78a<E T="03">et seq.</E>).</P>
        <P>On September 13, 1971, effective December 13, 1971 (<E T="03">see</E>36 FR 18641, September 18, 1971), the Commission adopted Rule 15c2-11 (Rule) under the Securities Exchange Act of 1934 (15 U.S.C. 78a<E T="03">et seq.</E>) to regulate the initiation or resumption of quotations in a quotation medium by a broker-dealer for over-the-counter (OTC) securities. The Rule was designed primarily to prevent certain manipulative and fraudulent trading schemes that had arisen in connection with the distribution and trading of unregistered securities issued by shell companies or other companies having outstanding but infrequently traded securities. Subject to certain exceptions, the Rule prohibits brokers-dealers from publishing a quotation for a security, or submitting a quotation for publication, in a quotation medium unless they have reviewed specified information concerning the security and the issuer.</P>
        <P>Based on information provided by Financial Industry Regulatory Authority, Inc. (FINRA), in the 2010 calendar year, FINRA received approximately 1,798 applications from broker-dealers to initiate or resume publication of covered OTC securities in the OTC Bulletin Board and/or the Pink Sheets or other quotation mediums. We estimate that (i) 41% of the covered OTC securities were issued by reporting issuers, while the other 59% were issued by non-reporting issuers, and (ii) it will take a broker-dealer about 4 hours to review, record and retain the information pertaining to a reporting issuer, and about 8 hours to review, record and retain the information pertaining to a non-reporting issuer.</P>
        <P>We therefore estimate that broker-dealers who initiate or resume publication of quotations for covered OTC securities of reporting issuers will require 2,949 hours (1,798 × 41% × 4) to review, record and retain the information required by the Rule. We estimate that broker-dealers who initiate or resume publication of quotations for covered OTC securities of non-reporting issuers will require 8,487 hours (1,798 × 59% × 8) to review, record and retain the information required by the Rule. Thus, we estimate the total annual burden hours for broker-dealers to initiate or resume publication of quotations of covered OTC securities to be 11,436 hours (2,949 + 8,487). The Commission believes that these 11,436 hours would be borne by staff working at a rate of $40 per hour.<SU>1</SU>
          <FTREF/>
        </P>
        <FTNT>
          <P>
            <SU>1</SU>
            <E T="03">See</E>Appendix C, SIFMA Office Salaries Data—Sept. 2007 for General Clerk national hourly rate.</P>
        </FTNT>
        <P>Subject to certain exceptions, the Rule prohibits brokers-dealers from publishing a quotation for a security, or submitting a quotation for publication, in a quotation medium unless they have reviewed specified information concerning the security and the issuer. The broker-dealer must also make the information reasonably available upon request to any person expressing an interest in a proposed transaction in the security with such broker or dealer. The collection of information that is submitted to FINRA for review and approval is currently not available to the public from FINRA.</P>

        <P>The Commission may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number. Background documentation for this information collection may be viewed at the following link,<E T="03">http://www.reginfo.gov.</E>Comments should be directed to: (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503, or by sending an e-mail to:<E T="03">Shagufta_Ahmed@omb.eop.gov;</E>and (ii) Thomas Bayer, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312 or send an e-mail to:<E T="03">PRA_Mailbox@sec.gov</E>. Comments must be submitted to OMB within 30 days of this notice.</P>
        <SIG>
          <DATED>Dated: May 31, 2011.</DATED>
          <NAME>Cathy H. Ahn,</NAME>
          <TITLE>Deputy Secretary.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13856 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8011-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <PRTPAGE P="32382"/>
        <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
        <DEPDOC>[Release No. 34-64562; File No. SR-ISE-2011-29]</DEPDOC>
        <SUBJECT>Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Second Market Fees</SUBJECT>
        <DATE>May 27, 2011.</DATE>
        <P>Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),<SU>1</SU>
          <FTREF/>and Rule 19b-4 thereunder,<SU>2</SU>
          <FTREF/>notice is hereby given that on May 18, 2011, the International Securities Exchange, LLC (the “Exchange” or the “ISE”) filed with the Securities and Exchange Commission the proposed rule change, as described in Items I and II below, which items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.</P>
        <FTNT>
          <P>
            <SU>1</SU>15 U.S.C. 78s(b)(1).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>2</SU>17 CFR 240.19b-4.</P>
        </FTNT>
        <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>

        <P>The ISE is proposing to amend its fees for executions in the Exchange's Second Market. The text of the proposed rule change is available on the Exchange's Web site (<E T="03">http://www.ise.com</E>), at the principal office of the Exchange, and at the Commission's Public Reference Room.</P>
        <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
        <P>In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in sections A, B and C below, of the most significant aspects of such statements.</P>
        <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
        <HD SOURCE="HD3">1. Purpose</HD>
        <P>The Exchange currently has rules for the listing and trading of low-volume option classes that qualify for listing under ISE Rule 502. These option classes trade in the Exchange's “Second Market.”<SU>3</SU>
          <FTREF/>The Exchange currently lists eligible equity option classes (excluding options on exchange traded funds) that trade on another options exchange and that have an average daily volume below 500 contracts over a six-month period in the Second Market. When the Exchange launched the Second Market, it adopted Second Market fees that varied from those that were and still are currently applicable to the Exchange's primary market. Specifically, for Second Market transactions, Members are currently charged an execution fee of $.05 per contract for Priority Customer<SU>4</SU>
          <FTREF/>orders. Priority Customer orders executed in the Exchange's primary market, on the other hand, are, for the most part, not charged an execution fee.<SU>5</SU>
          <FTREF/>
        </P>
        <FTNT>
          <P>
            <SU>3</SU>
            <E T="03">See</E>Exchange Act Release No. 34-54580 (October 6, 2006), 71 FR 60781 (October 16, 2006) (SR-ISE-2006-40).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>4</SU>A Priority Customer is defined in ISE Rule 100(a)(37A) as a person or entity that is not a broker/dealer in securities, and does not place more than 390 orders in listed options per day on average during a calendar month for its own beneficial account(s).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>5</SU>Priority Customer orders in Singly Listed Indexes, Singly Listed ETFs and FX Options that are not a part of the FX Options Incentive Plan are charged $0.18 per contract. Priority Customer orders in FX Options that are part of the FX Options Incentive Plan are charged $0.40 per contract.</P>
        </FTNT>
        <P>Further, the Exchange currently has a payment-for-order-flow (“PFOF”) program that helps its market makers establish PFOF arrangements with an Electronic Access Member (“EAM”) in exchange for that EAM preferencing some or all of its order flow to that market maker. The Exchange's PFOF fees are currently set at $0.65 per contract for all option classes that are not in the penny pilot program. For penny pilot classes, the Exchange charges a PFOF fee of $0.25 per contract. The Exchange currently does not charge a PFOF fee for option classes that are subject to the Exchange's maker/taker fees.<SU>6</SU>
          <FTREF/>And since the launch of the Second Market, ISE has not charged and currently does not charge a PFOF fee for Second Market transactions.</P>
        <FTNT>
          <P>
            <SU>6</SU>The exclusion applies to option classes that are subject to Rebates and Fees for Adding and Removing Liquidity in Select Symbols.</P>
        </FTNT>
        <P>The Exchange now proposes to amend its Second Market fees to standardize them with the fees charged for executions in the Exchange's primary market. Specifically, ISE proposes to lower the execution fee for Priority Customer orders in the Second Market from $0.05 per contract to $0.00 per contract. The Exchange also proposes to adopt a PFOF fee for Second Market transactions. In addition to standardizing theses fees, the Exchange believes these fee changes will make the Exchange's transaction fees simpler and more concise to Exchange Members. The Exchange believes that the proposed fee changes for Second Market transactions will encourage more order flow to the Exchange and also allow ISE market makers to better compete for order flow.</P>
        <P>The Exchange has designated this proposal to be operative on June 1, 2011.</P>
        <HD SOURCE="HD3">2. Basis</HD>
        <P>The Exchange believes that its proposal to amend its Schedule of Fees is consistent with Section 6(b) of the Act<SU>7</SU>
          <FTREF/>in general, and furthers the objectives of Section 6(b)(4) of the Act<SU>8</SU>
          <FTREF/>in particular, in that it is an equitable allocation of reasonable dues, fees and other charges among Exchange members. The Exchange believes that the proposed fee changes will generally allow the Exchange and its market makers to better compete for order flow and thus enhance competition. More specifically, the Exchange believes that its proposal to assess a $0.00 per contract fee for Second Market transactions is equitable and reasonable as it will standardize the fee charged by the Exchange for all market participants that trade in Second Market options. The Exchange believes that its proposal to assess a PFOF fee for Second Market transactions is also equitable and reasonable because the fee will serve to encourage order flow to the Exchange much like the PFOF fee does for option classes in the Exchange's primary market. Finally, the Exchange believes the proposed fee changes are equitable and reasonable as they will apply universally to all market participants who trade in Second Market options on the Exchange.</P>
        <FTNT>
          <P>
            <SU>7</SU>15 U.S.C. 78f(b).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>8</SU>15 U.S.C. 78f(b)(4).</P>
        </FTNT>
        <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
        <P>The proposed rule change does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.</P>
        <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others</HD>

        <P>The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.<PRTPAGE P="32383"/>
        </P>
        <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
        <P>The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.<SU>9</SU>
          <FTREF/>At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.</P>
        <FTNT>
          <P>
            <SU>9</SU>15 U.S.C. 78s(b)(3)(A)(ii).</P>
        </FTNT>
        <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
        <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
        <HD SOURCE="HD2">Electronic Comments</HD>
        <P>• Use the Commission's Internet comment form<E T="03">http://www.sec.gov/rules/sro.shtml);</E>or</P>
        <P>• Send an e-mail to<E T="03">rule-comments@sec.gov.</E>Please include File No. SR-ISE-2011-29 on the subject line.</P>
        <HD SOURCE="HD2">Paper Comments</HD>
        <P>• Send paper comments in triplicate to Elizabeth Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.</P>
        

        <FP>All submissions should refer to File Number SR-ISE-2011-29. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (<E T="03">http://www.sec.gov/rules/sro.shtml</E>). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room. Copies of such filing also will be available for inspection and copying at the principal office of the ISE. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ISE-2011-29 and should be submitted by June 27, 2011.</FP>
        <SIG>
          <P>For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.<SU>10</SU>
            <FTREF/>
          </P>
          <FTNT>
            <P>
              <SU>10</SU>17 CFR 200.30-3(a)(12).</P>
          </FTNT>
          <NAME>Cathy H. Ahn,</NAME>
          <TITLE>Deputy Secretary.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13855 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8011-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
        <DEPDOC>[Release No. 34-64570; File No. SR-BX-2011-029]</DEPDOC>
        <SUBJECT>Self-Regulatory Organizations; NASDAQ OMX BX; Notice of Filing and Immediate Effectiveness of a Proposal To Permit the Exchange To List Series With Additional Expiration Months If Such Series Are Listed on Another Exchange</SUBJECT>
        <DATE>May 31, 2011.</DATE>
        <P>Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)<SU>1</SU>
          <FTREF/>and Rule 19b-4 thereunder,<SU>2</SU>
          <FTREF/>notice is hereby given that, on May 23, 2011, NASDAQ OMX BX (the “Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange has designated the proposed rule change as constituting a non-controversial rule change under Rule 19b-4(f)(6) under the Act,<SU>3</SU>
          <FTREF/>which renders the proposal effective upon filing with the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.</P>
        <FTNT>
          <P>
            <SU>1</SU>15 U.S.C. 78s(b)(1).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>2</SU>17 CFR 240.19b-4.</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>3</SU>17 CFR 240.19b-4(f)(6).</P>
        </FTNT>
        <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>

        <P>The Exchange proposes to amend the Rules of the Boston Options Exchange Group, LLC (“BOX”) to permit the Exchange to list additional expiration months if such expiration months are listed on another exchange. The text of the proposed rule change is available at the Exchange's principal office, at<E T="03">http://www.nasdaqomxbx.cchwallstreet.com,</E>the Commission's Public Reference Room, and at the Commission's Web site at<E T="03">http://www.sec.gov.</E>
        </P>
        <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
        <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.</P>
        <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
        <HD SOURCE="HD3">1. Purpose</HD>
        <P>The purpose of the proposed rule change is to amend the BOX Trading Rules to permit the Exchange to list additional expiration months if such expiration months are listed on another exchange. This filing is based on a filing previously submitted by the International Securities Exchange, LLC.<SU>4</SU>
          <FTREF/>
        </P>
        <FTNT>
          <P>
            <SU>4</SU>
            <E T="03">See</E>Securities Exchange Act Release No. 64343 (April 26, 2011) 76 FR 24546 (May 2, 2011) (SR-ISE-2011-26).</P>
        </FTNT>

        <P>Under current Chapter IV, Section 6 of the BOX Trading Rules, the Exchange usually will open four (4) Expiration months for each type of option of a class of options open for trading on BOX: the first two (2) being the two nearest months, regardless of the quarterly cycle on which that class trades; the third and fourth being the next two months of the quarterly cycle previously designated by the Exchange for that specific class. For example, if the Exchange listed in late September a new stock option on a January-April-July-October quarterly cycle, the Exchange would list the two nearest-term months (October and November) and the next two expiration months of the cycle (January and April). Further, when the October series expire, the Exchange would add the December series as the next nearest month. And when the November series expire, the Exchange would add the July series as the next month of the cycle.<PRTPAGE P="32384"/>
        </P>
        <P>In 2010, the Exchange established a pilot program to add up to two additional expiration months for each class of options opened for trading on BOX (the “Additional Expiration Months Pilot”).<SU>5</SU>
          <FTREF/>Under the Additional Expiration Months Pilot, the Exchange lists expiration months that are considered “mid-month.” For example, for options classes that have expiration months of October, November, January, and April, the Exchange lists the December series. For options classes that have expiration months of October, November, February and May, the Exchange lists the December and January series. The listing of additional expiration months has been well-received by BOX Options Participants and has had a very limited impact on system resources.</P>
        <FTNT>
          <P>
            <SU>5</SU>
            <E T="03">See</E>Securities Exchange Act Release No. 63321 (November 16, 2010) 75 FR 71163 (November 22, 2010) (SR-BX-2010-077).</P>
        </FTNT>
        <P>ISE submitted a similar filing to one submitted by NASDAQ OMX PHLX, Inc. (“PHLX”).<SU>6</SU>
          <FTREF/>PHLX recently submitted a filing to adopt rules that permit it to list an unlimited number of expiration months and series for each class of standard options opened for trading on that exchange. Specifically, PHLX amended its rules so that it can open “at least one expiration month” for each class of standard options open for trading on that exchange. Consequently, while the Exchange is currently restricted to listing a limited number of expiration months that are permissible under its rules and the Additional Expiration Months Pilot, PHLX has the ability to list an unlimited number of expiration months, including those that the Exchange would not be able to currently list under its rules. Indeed, PHLX has listed additional expiration months that no other market, including the Exchange, could list at the time they were added. For example, in February 2011, PHLX listed the October 2011 expiration in Omnicare, Inc. (ticker: OCR). PHLX was able to list that expiration month based on its amended rule. Meanwhile, the Exchange could not list the October 2011 series under Chapter IV, Section 6(a) of the BOX Trading Rules because the standard expiration months for OCR in February are March, April, June, and September. The Exchange also could not list the October 2011 series as part of the Additional Expiration Months Pilot because OCR is not one of the classes selected by BOX to participate in the Additional Expiration Months Pilot. As a result, PHLX was the only exchange that listed the October 2011 series in OCR and traded that series without any competition until recently when other options exchanges amended their rules to permit its listing.</P>
        <FTNT>
          <P>
            <SU>6</SU>
            <E T="03">See</E>Securities Exchange Act Release No. 63700 (January 11, 2011) 76 FR 2931 (January 18, 2011) (SR-PHLX-2011-04). In its filing, PHLX cites to the Commission's approval of the NASDAQ Options Market and rules pertaining thereto as the basis for making the change to its rules.</P>
        </FTNT>
        <P>For competitive reasons, the Exchange now proposes to add new Supplementary Material .09 to its Chapter IV, Section 6 and Supplementary Material .03 to Chapter XIV, Section 10 of the BOX Trading Rules to permit the Exchange to list additional expiration months on options classes opened for trading on BOX if such expiration months are opened for trading on at least one other national securities exchange. This proposed rule change will allow the Exchange to match the listing of expiration months that PHLX, NOM, ISE, or other exchanges list in the event the Exchange is not able to list those expiration months because they do not comport to BOX Trading Rules or the Additional Expiration Months Pilot.</P>
        <P>BOX notes that the proposed rule change affords additional flexibility in that it will permit listing those additional expiration months that have an actual demand from market participants, thereby potentially reducing the proliferation of classes and series. The Exchange believes the proposed rule change is proper, and indeed necessary, in light of the need to have rules that permit the listing of identical expiration months across exchanges for products that are multiply-listed and fungible with one another.</P>
        <P>BOX believes that the proposed rule change should encourage competition and be beneficial to traders and market participants by providing them with a means to trade on BOX securities that are listed and traded on other exchanges.</P>
        <HD SOURCE="HD3">2. Statutory Basis</HD>
        <P>The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,<SU>7</SU>
          <FTREF/>in general, and Section 6(b)(5) of the Act,<SU>8</SU>
          <FTREF/>in particular, in that it is designed to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism for a free and open market and a national market system, and in general, to protect investors and the public interest. In particular, the proposed rule change will permit the Exchange to accommodate requests made by BOX Option Participants and other market participants to list the additional expiration months and thus encourage competition without harming investors or the public interest.</P>
        <FTNT>
          <P>
            <SU>7</SU>15 U.S.C. 78f(b).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>8</SU>15 U.S.C. 78f(b)(5).</P>
        </FTNT>
        <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
        <P>The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.</P>
        <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
        <P>No written comments were either solicited or received.</P>
        <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
        <P>Because the foregoing proposed rule change does not significantly affect the protection of investors or the public interest, does not impose any significant burden on competition, and, by its terms, does not become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act<SU>9</SU>
          <FTREF/>and Rule 19b-(f)(6) thereunder.<SU>10</SU>
          <FTREF/>
        </P>
        <FTNT>
          <P>
            <SU>9</SU>15 U.S.C. 78s(b)(3)(A).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>10</SU>17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to give the Commission written notice of the Exchange's intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Commission has waived the five-day prefiling requirement in this case.</P>
        </FTNT>
        <P>The Exchange has requested that the Commission waive the 30-day operative delay. The Commission believes that waiver of the operative delay is consistent with the protection of investors and the public interest because the proposal should promote competition by allowing the Exchange, without undue delay, to list and trade option series that are trading on other options exchanges. Therefore, the Commission designates the proposal operative upon filing.<SU>11</SU>
          <FTREF/>
        </P>
        <FTNT>
          <P>

            <SU>11</SU>For purposes only of waiving the 30-day operative delay, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation.<E T="03">See</E>15 U.S.C. 78c(f).</P>
        </FTNT>

        <P>At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if<PRTPAGE P="32385"/>it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.</P>
        <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
        <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
        <HD SOURCE="HD2">Electronic Comments</HD>
        <P>• Use the Commission's Internet comment form (<E T="03">http://www.sec.gov/rules/sro.shtml</E>); or</P>
        <P>• Send an e-mail to<E T="03">rule-comments@sec.gov.</E>Please include File Number SR-BX-2011-029 on the subject line.</P>
        <HD SOURCE="HD2">Paper Comments</HD>
        <P>• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.</P>
        

        <FP>All submissions should refer to File Number SR-BX-2011-029. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (<E T="03">http://www.sec.gov/rules/sro.shtml</E>). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street, NE., Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-BX-2011-029 and should be submitted on or before June 27, 2011.</FP>
        <SIG>
          <P>For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.<SU>12</SU>
            <FTREF/>
          </P>
          
          <FTNT>
            <P>
              <SU>12</SU>17 CFR 200.30-3(a)(12).</P>
          </FTNT>
          <NAME>Cathy H. Ahn,</NAME>
          <TITLE>Deputy Secretary.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13903 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8011-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
        <DEPDOC>[Release No. 34-64571; File No. SR-Phlx-2011-72]</DEPDOC>
        <SUBJECT>Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Extending the Pilot Period To Allow Cabinet Trading To Take Place Below $1 Per Option Contract</SUBJECT>
        <DATE>May 31, 2011.</DATE>
        <P>Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)<SU>1</SU>
          <FTREF/>and Rule 19b-4 thereunder,<SU>2</SU>
          <FTREF/>notice is hereby given that on May 20, 2011, NASDAQ OMX PHLX LLC (“Phlx” or the “Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange has designated the proposed rule change as constituting a non-controversial rule change under Rule 19b-4(f)(6) under the Act,<SU>3</SU>
          <FTREF/>which renders the proposal effective upon filing with the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.</P>
        <FTNT>
          <P>
            <SU>1</SU>15 U.S.C. 78s(b)(1).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>2</SU>17 CFR 240.19b-4.</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>3</SU>17 CFR 240.19b-4(f)(6).</P>
        </FTNT>
        <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
        <P>The Exchange submits this proposed rule change to extend through December 1, 2011, the pilot program in Rule 1059, Accomodation Transactions, to allow cabinet trading to take place below $1 per option contract, under specified circumstances (the “pilot program”).</P>
        <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
        <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.</P>
        <HD SOURCE="HD2">A.<E T="03">Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</E>
        </HD>
        <HD SOURCE="HD3">1. Purpose</HD>
        <P>The purpose is to extend through December 1, 2011, the pilot program in Commentary .02 of Exchange Rule 1059, Accommodation Transactions, which sets forth specific procedures for engaging in cabinet trades.<SU>4</SU>
          <FTREF/>Prior to the pilot program, Rule 1059 required that all orders placed in the cabinet were assigned priority based upon the sequence in which such orders were received by the specialist. All closing bids and offers would be submitted to the specialist in writing, and the specialist effected all closing cabinet transactions by matching such orders placed with him. Bids or offers on orders to open for the accounts of customer, firm, specialists and ROTs could be made at $1 per option contract, but such orders could not be placed in and must yield to all orders in the cabinet. Specialists effected all cabinet transactions by matching closing purchase or sale orders which were placed in the cabinet or, provided there was no matching closing purchase or sale order in the cabinet, by matching a closing purchase or sale order in the cabinet with an opening purchase or sale order.<SU>5</SU>
          <FTREF/>All cabinet transactions were reported to the Exchange following the close of each business day.<SU>6</SU>

          <FTREF/>Any (i) Member, (ii) member organization, or (iii) other person who was a non-member broker or dealer and who directly or indirectly controlled, was controlled by, or was under common control with, a member or member organization (any such other person being referred to as an affiliated person) could effect any transaction as principal in the over-the-counter market in any class of option contracts listed on the<PRTPAGE P="32386"/>Exchange for a premium not in excess of $1.00 per contract.</P>
        <FTNT>
          <P>
            <SU>4</SU>Cabinet or accommodation trading of option contracts is intended to accommodate persons wishing to effect closing transactions in those series of options dealt in on the Exchange for which there is no auction market.</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>5</SU>Specialists and ROTs are not subject to the requirements of Rule 1014 in respect of orders placed pursuant to this Rule. Also, the provisions of Rule 1033(b) and (c), Rule 1034 and Rule 1038 do not apply to orders placed in the cabinet. Cabinet transactions are not reported on the ticker.</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>6</SU>
            <E T="03">See</E>Exchange Rule 1059.</P>
        </FTNT>
        <P>On December 30, 2010, the Exchange filed an immediately effective proposal that established the pilot program being extended by this filing. The pilot program allows transactions to take place in open outcry at a price of at least $0 but less than $1 per option contract until June 1, 2011 (the “pilot program”).<SU>7</SU>
          <FTREF/>These lower priced transactions are traded pursuant to the same procedures applicable to $1 cabinet trades, except that pursuant to the pilot program (i) Bids and offers for opening transactions are only permitted to accommodate closing transactions in order to limit use of the procedure to liquidations of existing positions, and (ii) the procedures are also made available for trading in options participating in the Penny Pilot Program.<SU>8</SU>
          <FTREF/>
        </P>
        <FTNT>
          <P>
            <SU>7</SU>PHLX Rule 1059, Commentary .02;<E T="03">See</E>Securities Exchange Act Release No. 63626 (December 30, 2010), 76 FR 812 (January 6, 2011) (SR-PHLX-2010-185).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>8</SU>Prior to the pilot, the $1 cabinet trading procedures were limited to options classes traded in $0.05 or $0.10 standard increments. The $1 cabinet trading procedures were not available in Penny Pilot Program classes because in those classes, an option series could trade in a standard increment as low as $0.01 per share (or $1.00 per option contract with a 100 share multiplier). The pilot allows trading below $0.01 per share (or $1.00 per option contract with a 100 share multiplier) in all classes, including those classes participating in the Penny Pilot Program.</P>
        </FTNT>

        <P>The Exchange believes that allowing a price of at least $0 but less than $1 will better accommodate the closing of options positions in series that are worthless or not actively traded, particularly due to recent market conditions which have resulted in a significant number of series being out-of-the-money. For example, a market participant might have a long position in a call series with a strike price of $100 and the underlying stock might now be trading at $30. In such an instance, there might not otherwise be a market for that person to close-out its position even at the $1 cabinet price (<E T="03">e.g.,</E>the series might be quoted no bid).</P>
        <P>The Exchange hereby seeks to extend the previously approved pilot period for such $1 cabinet trading for an additional six months through December 1, 2011 so that the procedures can continue without interruptions while the Exchange considers whether to seek permanent approval of the temporary procedure.</P>
        <HD SOURCE="HD3">2. Statutory Basis</HD>
        <P>The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,<SU>9</SU>
          <FTREF/>in general, and with Section 6(b)(5) of the Act,<SU>10</SU>
          <FTREF/>in particular, in that the proposal is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Specifically, the Exchange believes that allowing for liquidations at a price less than $1 per option contract pursuant to the pilot program will better facilitate the closing of options positions that are worthless or not actively trading, especially in Penny Pilot issues where cabinet trades are not otherwise permitted. The Exchange believes the extension is of sufficient length to permit both the Exchange and the Commission to assess the impact of the Exchange's authority to allow transactions to take place in open outcry at a price of at least $0 but less than $1 per option in accordance with its attendant obligations and conditions.</P>
        <FTNT>
          <P>
            <SU>9</SU>15 U.S.C. 78f.</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>10</SU>15 U.S.C. 78f(b)(5).</P>
        </FTNT>
        <HD SOURCE="HD2">B.<E T="03">Self-Regulatory Organization's Statement on Burden on Competition</E>
        </HD>
        <P>The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, as amended.</P>
        <HD SOURCE="HD2">C.<E T="03">Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</E>
        </HD>
        <P>No written comments were either solicited or received.</P>
        <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
        <P>Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act<SU>11</SU>
          <FTREF/>and Rule 19b-4(f)(6) thereunder.<SU>12</SU>
          <FTREF/>
        </P>
        <FTNT>
          <P>
            <SU>11</SU>15 U.S.C. 78s(b)(3)(A).</P>
        </FTNT>
        <FTNT>
          <P>
            <SU>12</SU>17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires the self-regulatory organization to submit to the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Exchange has satisfied this requirement.</P>
        </FTNT>
        <P>The Exchange has requested that the Commission waive the 30-day operative delay. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, because waiver of the 30-day operative delay will enable the benefits of the pilot program to continue without interruption for a six-month period. Accordingly, the Commission designates the proposed rule change operative upon filing with the Commission.<SU>13</SU>
          <FTREF/>
        </P>
        <FTNT>
          <P>

            <SU>13</SU>For the purposes only of waiving the 30-day operative delay, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation.<E T="03">See</E>15 U.S.C. 78(c)(f).</P>
        </FTNT>
        <P>At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.</P>
        <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
        <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
        <HD SOURCE="HD2">Electronic Comments</HD>
        <P>• Use the Commission's Internet comment form (<E T="03">http://www.sec.gov/rules/sro.shtml</E>); or</P>
        <P>• Send an e-mail to<E T="03">rule-comments@sec.gov.</E>Please include File Number SR-Phlx-2011-72 on the subject line.</P>
        <HD SOURCE="HD2">Paper Comments</HD>
        <P>• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.</P>
        

        <FP>All submissions should refer to File Number SR-Phlx-2011-72. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (<E T="03">http://www.sec.gov/rules/sro.shtml</E>). Copies of the submission, all subsequent amendments, all written statements<PRTPAGE P="32387"/>with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room on official business days between the hours of 10 a.m. and 3 p.m. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-Phlx-2011-72 and should be submitted on or before June 27, 2011.</FP>
        <SIG>
          <P>For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.<SU>14</SU>
            <FTREF/>
          </P>
          <FTNT>
            <P>
              <SU>14</SU>17 CFR 200.30-3(a)(12).</P>
          </FTNT>
          <NAME>Cathy H. Ahn,</NAME>
          <TITLE>Deputy Secretary.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13876 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8011-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">SMALL BUSINESS ADMINISTRATION</AGENCY>
        <DEPDOC>[Disaster Declaration #12599 and #12600]</DEPDOC>
        <SUBJECT>Kentucky Disaster Number KY-00040</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>U.S. Small Business Administration.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Amendment 2.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This is an amendment of the Presidential declaration of a major disaster for the Commonwealth of Kentucky (FEMA-1976-DR), dated 05/19/2011.</P>
          <P>
            <E T="03">Incident:</E>Severe Storms, Tornadoes, and Flooding.</P>
          <P>
            <E T="03">Incident Period:</E>04/22/2011 through 05/20/2011.</P>
          <P>
            <E T="03">Effective Date:</E>05/26/2011.</P>
          <P>
            <E T="03">Physical Loan Application Deadline Date:</E>07/18/2011.</P>
          <P>
            <E T="03">EIDL Loan Application Deadline Date:</E>02/21/2012.</P>
        </SUM>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit completed loan applications to: U.S. Small Business Administration, Processing And Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of the Presidential disaster declaration for the Commonwealth of KENTUCKY, dated 05/19/2011 is hereby amended to include the following areas as adversely affected by the disaster:</P>
        
        <FP SOURCE="FP-1">
          <E T="03">Primary Counties: (Physical Damage and Economic Injury Loans):</E>Ballard, Daviess, Henderson, Lawrence, McLean, Pike.</FP>
        <FP SOURCE="FP-2">
          <E T="03">Contiguous Counties: (Economic Injury Loans Only):</E>
        </FP>
        <FP SOURCE="FP1-2">Kentucky: Elliott, Floyd, Hancock, Johnson, Knott, Letcher, Martin, Morgan, Muhlenberg, Ohio.</FP>
        <FP SOURCE="FP1-2">Illinois: Alexander.</FP>
        <FP SOURCE="FP1-2">Indiana: Spencer, Vanderburgh, Warrick.</FP>
        <FP SOURCE="FP1-2">Virginia: Buchanan, Dickenson, Wise.</FP>
        <FP SOURCE="FP1-2">West Virginia: Mingo.</FP>
        
        <P>All other information in the original declaration remains unchanged.</P>
        
        <EXTRACT>
          <FP>(Catalog of Federal Domestic Assistance Numbers 59002 and 59008)</FP>
        </EXTRACT>
        <SIG>
          <NAME>James E. Rivera,</NAME>
          <TITLE>Associate Administrator for Disaster Assistance.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13846 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8025-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
        <DEPDOC>[Disaster Declaration #12572 and #12573]</DEPDOC>
        <SUBJECT>Tennessee Disaster Number TN-00053</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>U.S. Small Business Administration.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Amendment 1.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This is an amendment of the Presidential declaration of a major disaster for the State of  Tennessee (FEMA-1979-DR), dated 05/09/2011.</P>
          <P>
            <E T="03">Incident:</E>Severe Storms, Tornadoes, Straight-line, Winds, and Flooding.</P>
          <P>
            <E T="03">Incident Period:</E>04/19/2011 and continuing.</P>
          <P>
            <E T="03">Effective Date:</E>05/26/2011.</P>
          <P>
            <E T="03">Physical Loan Application Deadline Date:</E>07/08/2011.</P>
          <P>
            <E T="03">EIDL Loan Application Deadline Date:</E>02/09/2012.</P>
        </SUM>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit completed loan applications to:U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of the Presidential disaster declaration for the State of Tennessee, dated 05/09/2011 is hereby amended to include the following areas as adversely affected by the disaster:</P>
        
        <FP SOURCE="FP-1">
          <E T="03">Primary Counties:</E>(Physical Damage and Economic Injury Loans): Gibson, Lauderdale.</FP>
        <FP SOURCE="FP-2">
          <E T="03">Contiguous Counties:</E>(Economic Injury Loans Only): Tennessee: Carroll, Haywood, Madison.</FP>
        
        <P>All other information in the original declaration remains unchanged.</P>
        
        <EXTRACT>
          <FP>(Catalog of Federal Domestic Assistance Numbers 59002 and 59008)</FP>
        </EXTRACT>
        <SIG>
          <NAME>James E. Rivera,</NAME>
          <TITLE>Associate Administrator for Disaster Assistance.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13847 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8025-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
        <SUBAGY>Disaster Declaration #12566 and #12567</SUBAGY>
        <SUBJECT>Kentucky Disaster Number KY-00039</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>U.S. Small Business Administration.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Amendment 4.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Kentucky (FEMA-1976-DR), dated 05/04/2011.</P>
          <P>
            <E T="03">Incident:</E>Severe Storms, Tornadoes, and Flooding.</P>
          <P>
            <E T="03">Incident Period:</E>04/22/2011 through 05/20/2011.</P>
          <P>
            <E T="03">Effective Date:</E>05/25/2011.</P>
          <P>
            <E T="03">Physical Loan Application Deadline Date:</E>07/05/2011.</P>
          <P>
            <E T="03">Economic Injury (EIDL) Loan Application Deadline Date:</E>02/06/2012.</P>
        </SUM>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of the President's major disaster declaration for Private Non-Profit organizations in the Commonwealth of KENTUCKY, dated 05/04/2011, is hereby amended to include the following areas as adversely affected by the disaster.</P>
        
        <FP SOURCE="FP-1">
          <E T="03">Primary Counties:</E>Ballard, Breckinridge, Crittenden, Daviess, Floyd, Grayson, Hancock, Henderson, Hickman, Johnson, Knott, Livingston, Magoffin,<PRTPAGE P="32388"/>Marshall, Martin, McLean, Meade, Perry, Webster, Wolfe.</FP>
        
        <P>All other information in the original declaration remains unchanged.</P>
        
        <EXTRACT>
          <FP>(Catalog of Federal Domestic Assistance Numbers 59002 and 59008)</FP>
        </EXTRACT>
        <SIG>
          <NAME>Joseph P. Loddo,</NAME>
          <TITLE>Acting Associate Administrator for Disaster Assistance.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13848 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8025-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
        <DEPDOC>[Disaster Declaration # 12588 and # 12589]</DEPDOC>
        <SUBJECT>Minnesota Disaster Number MN-00030</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>U.S. Small Business Administration.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Amendment 1.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Minnesota (FEMA-1982-DR), dated 05/10/2011.</P>
          <P>
            <E T="03">Incident:</E>Severe Storms and Flooding.</P>
          <P>
            <E T="03">Incident Period:</E>03/16/2011 and continuing.</P>
          <P>
            <E T="03">Effective Date:</E>05/24/2011.</P>
          <P>
            <E T="03">Physical Loan Application Deadline Date:</E>07/11/2011.</P>
          <P>
            <E T="03">Economic Injury (EIDL) Loan Application Deadline Date:</E>02/10/2012.</P>
        </SUM>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of MINNESOTA, dated 05/10/2011, is hereby amended to include the following areas as adversely affected by the disaster.</P>
        
        <FP SOURCE="FP-1">
          <E T="03">Primary Counties:</E>Becker, Beltrami, Kittson, Marshall, Norman, Otter Tail, Polk, Ramsey, Red Lake,  Roseau, Swift, Washington, Wright, and the Red Lake Reservation.</FP>
        <P>All other information in the original declaration remains unchanged.</P>
        
        <EXTRACT>
          <FP>(Catalog of Federal Domestic Assistance Numbers 59002 and 59008)</FP>
        </EXTRACT>
        <SIG>
          <NAME>James E. Rivera,</NAME>
          <TITLE>Associate Administrator for Disaster Assistance.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13849 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 8025-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF STATE</AGENCY>
        <DEPDOC>[Public Notice 7486]</DEPDOC>
        <SUBJECT>Determination and Waiver Relating to Assistance for the Independent States of the Former Soviet Union</SUBJECT>
        <P>Determination and Waiver of Section 7073(a) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2010 (Div. F, Pub. L. 111-117), as carried forward under the Full-Year Continuing Appropriations Act, 2011 (Div. B, Pub. L. 112-10) (“the Act”) Relating to Assistance for the Independent States of the Former Soviet Union.</P>
        <P>Pursuant to the authority vested in me as Deputy Secretary of State, including by section Section 7073(a) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2010 (Div. F, Pub. L. 111-117), as carried forward under the Full-Year Continuing Appropriations Act, 2011 (Div. B, Pub. L. 112-10) (“the Act”), Executive Order 13118 of March 31, 1999, and State Department Delegation of Authority No. 245-1, I hereby determine that it is in the national security interest of the United States to make available funds appropriated under the heading “Assistance for Europe, Eurasia and Central Asia” of the Act, without regard to the restriction in section 7073(a).</P>

        <P>This determination shall be reported to the Congress and published in the<E T="04">Federal Register</E>.</P>
        <SIG>
          <DATED>Dated: May 23, 2011.</DATED>
          <NAME>James B. Steinberg,</NAME>
          <TITLE>Deputy Secretary of State.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13920 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4710-23-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF STATE</AGENCY>
        <DEPDOC>[Public Notice 7484]</DEPDOC>
        <SUBJECT>Waiver of Restriction on Assistanceto the Central Government of Dominican Republic</SUBJECT>
        <P>Pursuant to Section 7086(c)(2) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2010 (Div. F, Pub. L. 111-117) as carried forward by the Full-Year Continuing Appropriations Act, 2011 (Div. B, Pub. L. 112-10) (“the Act”), and Department of State Delegation of Authority Number 245-1, I hereby determine that it is important to the national interest of the United States to waive the requirements of Section 7086(c)(1) of the Act with respect to the Dominican Republic and I hereby waive such restriction.</P>

        <P>This determination shall be reported to the Congress, and published in the<E T="04">Federal Register</E>.</P>
        <SIG>
          <DATED>Dated: May 26, 2011.</DATED>
          <NAME>Thomas Nides,</NAME>
          <TITLE>Deputy Secretary of Statefor Management and Resources.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13919 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4710-29-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
        <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
        <DEPDOC>[Docket No. FMCSA-2011-0065]</DEPDOC>
        <SUBJECT>Agency Information Collection Activities; Request for Comment; Extension of an Information Collection: Hours of Service (HOS) of Drivers Regulations</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Motor Carrier Safety Administration (FMCSA), DOT.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>

          <P>In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment. The FMCSA requests OMB approval to revise and extend an existing ICR entitled, “Hours of Service (HOS) of Drivers Regulations.” The hours-of-service (HOS) rules require most commercial motor vehicle (CMV) drivers to maintain on the CMV an accurate record of duty status (RODS) in either paper or electronic form. The Agency, effective June 4, 2010, authorized the use of electronic on-board recorders (EOBRs) to create driver RODS. This ICR estimates, for the first time, the paperwork burden of motor carriers<E T="03">voluntarily</E>using EOBRs. This ICR promotes safety in CMV operations by assisting motor carriers and enforcement officials in monitoring compliance with the HOS rules.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Comments must be submitted on or before August 5, 2011.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>You may submit comments identified by Federal Docket Management System (FDMS) Docket Number FMCSA-2011-0065 using any of the following methods:</P>
          <P>
            <E T="03">Web site:</E>Federal eRulemaking Portal:<E T="03">http://www.regulations.gov.</E>Follow the online instructions for submitting comments.</P>
          <P>
            <E T="03">Fax:</E>1-202-493-2251.</P>
          <P>
            <E T="03">Mail:</E>Docket Management Facility; U.S. Department of Transportation, 1200<PRTPAGE P="32389"/>New Jersey Avenue, SE., West Building, Ground Floor, Room W12-140, 20590-0001.</P>
          <P>
            <E T="03">Hand Delivery or Courier:</E>West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m. E.T., Monday through Friday, except Federal holidays.</P>
          <P>
            <E T="03">Instructions:</E>All submissions must include the Agency name and docket number. For detailed instructions on submitting comments and additional information on the exemption process, see the Public Participation heading below. Note that all comments received will be posted without change to<E T="03">http://www.regulations.gov,</E>including any personal information provided. Please see the Privacy Act heading below.</P>
          <P>
            <E T="03">Docket:</E>For access to the docket to read background documents or comments received, go to<E T="03">http://www.regulations.gov,</E>and follow the online instructions for accessing the dockets, or go to the street address listed above.</P>
          <P>
            <E T="03">Privacy Act:</E>Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union,<E T="03">etc.</E>). You may review DOT's complete Privacy Act Statement for the Federal Docket Management System published in the<E T="04">Federal Register</E>on January 17, 2008 (73 FR 3316), or you may visit<E T="03">http://edocket.access.gpo.gov/2008/pdfE8-794.pdf.</E>
          </P>
          <P>
            <E T="03">Public Participation:</E>The Federal eRulemaking Portal is available 24 hours each day, 365 days each year. You can obtain electronic submission and retrieval help and guidelines under the “help” section of the Federal eRulemaking Portal Web site. If you want us to notify you that we received your comments, please include a self-addressed, stamped envelope or postcard, or print the acknowledgement page that appears after submitting comments online. Comments received after the comment closing date will be included in the docket and will be considered to the extent practicable.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Mr. Thomas Yager, Chief, FMCSA Driver and Carrier Operations Division.<E T="03">Telephone:</E>202-366-4325.<E T="03">E-mail: MCPSD@dot.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>
        <P SOURCE="NPAR">
          <E T="03">Background:</E>The FMCSA regulates the amount of time a CMV driver may drive or otherwise be on duty, in order to ensure that an adequate period of time is available to the driver to rest. A driver must accurately record his or her duty status (driving, on duty not driving, off duty, sleeper berth) at all points during the 24-hour period designated by the motor carrier (49 CFR 395.8(a)(1)). This record of duty status (RODS) must be made on a grid specified by subsection 395.8(g). The term “logbook” is often used in the industry to denote the collection of the most recent RODS of the driver. A driver must have the RODS for the previous 7 consecutive days in the CMV at all times (395.8(k)(2)). The RODS must be submitted to the motor carrier along with any supporting documents, such as fuel receipts and toll tickets that could assist in verifying the accuracy of entries on the RODS, and the motor carrier must retain these records for a minimum of 6 months from the date of receipt (49 CFR 395.8(k)(1)).</P>

        <P>Statutory authority for regulating the hours of service (HOS) of drivers operating CMVs in interstate commerce is derived from 49 U.S.C. 31136 and 31502. The penalty provisions are located at 49 U.S.C. 521, 522 and 526, as amended. On November 28, 1982, the Federal Highway Administration (FHWA), the agency responsible for administration of the Federal Motor Carrier Safety Regulations (49 CFR 350<E T="03">et seq.</E>)(FMCSRs) at that time, promulgated a final rule requiring motor carriers to ensure that their drivers record their duty status in a specified format and verify the accuracy of the HOS of each driver (47 FR 53383). The rule is codified at 49 CFR 395.8. The FMCSRs also state:</P>
        <EXTRACT>
          
          <P>“No driver shall operate a commercial motor vehicle, and a commercial motor carrier shall not require or permit a driver to operate a commercial motor vehicle, while the driver's ability or alertness is so impaired, or so likely to become impaired, through fatigue, illness, or any other cause, as to make it unsafe for him/her to begin or continue to operate the commercial motor vehicle” (49 CFR 392.3).</P>
        </EXTRACT>
        
        <FP>The HOS rules provide four methods of recording driver duty status:</FP>
        <P>(1)<E T="03">Paper RODS:</E>This grid form requires the driver to graph time and location on a paper record over a 24-hour period (Section 395.8(g)). It must be present on the CMV in the absence of a regulatory exception.</P>
        <P>(2)<E T="03">Time Record:</E>The HOS regulations allow certain “short haul” CMV drivers to avoid the onboard-the-CMV RODS requirement if their motor carrier records their HOS by means of a time record or time card maintained at the place of business (Section 395.1(e)). To qualify for this exception, short-haul drivers generally must return at the end of the duty day to the same location at which they began the day, and must remain within a certain distance of that location at all times during the duty day. The time record must show the time the driver began work, was released from work, and the total hours worked.</P>
        <P>(3)<E T="03">Automatic On-Board Recording Device (AOBRD):</E>An electronic record is permitted if it is created and maintained by an AOBRD as defined by 49 CFR 395.2. The record must include all the information that would appear on a paper log, and the driver or carrier must be capable of producing this information upon demand.</P>
        <P>(4)<E T="03">EOBR:</E>Motor carriers subject to an FMCSA remedial directive must use an electronic record created and maintained by an EOBR as defined in 49 CFR 395.2. Other motor carriers may voluntarily employ EOBRs.</P>
        <P>The RODS is important because it provides motor carriers and enforcement personnel a significant tool for determining driver compliance with the HOS rules. Compliance helps FMCSA protect the public by reducing the number of tired CMV drivers on the highways.</P>
        <P>Most States receive grants from FMCSA under the Motor Carrier Safety Assistance Program. As a condition of receiving these grants, States agree to adopt and enforce the FMCSRs, including the HOS rules, as State law. As a result, State enforcement inspectors use the RODS and supporting documents to determine whether CMV drivers are complying with the HOS rules. In addition, FMCSA uses the RODS during on-site compliance reviews (CRs) and targeted reviews of motor carriers. The CR is a public record. An unfavorable review can be damaging to a motor carrier's business because customers may access the CRs before selecting a motor carrier to hire. Finally, Federal and State judicial systems generally accept RODS as evidence in actions alleging driver of motor carrier violation of the HOS regulations. This information collection supports the DOT's Strategic Goal of Safety because the information helps the Agency ensure the safe operation of CMVs in interstate commerce on our Nation's highways.</P>

        <P>The currently-approved PRA burden estimate is 181.28 million hours, as approved by OMB on August 20, 2010. The expiration date of this IC is August 31, 2011. In this ICR, FMCSA proposes to reduce the PRA burden by approximately 9.20 million burden hours, or by slightly over 5 per cent. FMCSA seeks OMB approval of its revised estimated PRA burden of 172.08 million burden hours. In today's<PRTPAGE P="32390"/>submission, FMCSA for the first time estimates the extent of<E T="03">voluntary</E>EOBR use by motor carriers, and subtracts that same number from its estimate of the extent of the use of written RODS. The Agency maintains its OMB-approved estimates of the total number of CMV drivers subject to the HOS rules, and the total number of CMV drivers subject to an Agency remedial HOS directive.</P>
        <P>By this notice, the Agency seeks public comment on its revised estimate of the paperwork burden of the HOS rules.</P>
        <P>
          <E T="03">Title:</E>Hours of Service (HOS) of Drivers Regulations.</P>
        <P>
          <E T="03">OMB Control Number:</E>2126-0001.</P>
        <P>
          <E T="03">Type of Request:</E>Revision and extension of a currently-approved information collection.</P>
        <P>
          <E T="03">Respondents:</E>Motor Carriers, Drivers of CMVs.</P>
        <P>
          <E T="03">Estimated Annual Respondents:</E>4.93 million [4.60 million drivers + 0.33 million active motor carriers = 4.93 million respondents].</P>
        <P>
          <E T="03">Estimated Time per Response:</E>A driver employing a paper RODS takes an average of 6.5 minutes to complete it; a driver employing an EOBR takes an average of 2 minutes to complete it. A driver takes an average of 5 minutes to forward a paper RODS to the motor carrier; a driver employing an EOBR is relieved of this task by automation. Whether using a paper or EOBR RODS, a motor carrier takes 2 minutes to review a RODS and its corresponding supporting documents, and 1 additional minute to maintain those supporting documents. For those motor carriers using an EOBR, the ICR burden of maintaining the RODS is eliminated by automation; for those motor carriers using paper RODS, 1 minute is required to maintain the RODS.</P>
        <P>
          <E T="03">Expiration Date:</E>8/31/2011.</P>
        <P>
          <E T="03">Estimated Frequency of Response:</E>
        </P>
        <P>
          <E T="03">Drivers:</E>240 days per year, on average.</P>
        <P>
          <E T="03">Motor Carriers:</E>240 days per year, on average.</P>
        <P>
          <E T="03">Estimated Annual Responses:</E>3,843.59 million—the sum of the following:</P>
        <HD SOURCE="HD1">A. Driver Tasks</HD>
        <P>(1) Filling out the RODS: 1,104 million, and</P>
        <P>(2) Forwarding the RODS to the motor carrier: 102.23 million.</P>
        <HD SOURCE="HD1">B. Motor Carrier Tasks</HD>
        <P>(1) Reviewing the RODS: 552 million,</P>
        <P>(2) Maintaining the RODS: 981.36 million, and</P>
        <P>(3) Maintaining the supporting documents: 1,104 million.</P>
        <P>
          <E T="03">Estimated Total Annual Burden:</E>172.08 million burden hours [118.92 million driver hours + 53.16 million carrier hours = 172.08].</P>
        <P>
          <E T="03">Public Comments Invited:</E>You are asked to comment on any aspect of this information collection, including: (1) Whether the proposed collection is necessary for the performance of FMCSA's functions; (2) the accuracy of the estimated burden; (3) ways for the FMCSA to enhance the quality, usefulness, and clarity of the collected information; and (4) ways that the burden could be minimized without reducing the quality of the information collected. The Agency will summarize or include your comments in the request for OMB's clearance of this ICR.</P>
        <SIG>
          <DATED>Issued on: May 27, 2011.</DATED>
          <NAME>Kelly Leone,</NAME>
          <TITLE>Associate Administrator for Research and Information Technology.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13900 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
        <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
        <DEPDOC>[Docket No. FMCSA-2006-26367]</DEPDOC>
        <SUBJECT>Motor Carrier Safety Advisory Committee Public Meeting</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Motor Carrier Safety Administration (FMCSA), DOT.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of Motor Carrier Safety Advisory Committee (MCSAC) Meeting.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>FMCSA announces that MCSAC will hold a committee meeting from Monday, June 20 through Wednesday, June 22, 2011. The meeting will be open to the public for its duration. The MCSAC will complete action on Task 11-01, regarding Patterns of Safety Violations by Motor Carrier Management and will begin work on Tasks 11-02, regarding Roadside violation severity weightings in the Carrier Safety Measurement System (CSMS) in FMCSA's Compliance, Safety, Accountability (CSA) program, and 11-03, regarding Oversight of the Agency's Long-Haul Cross Border Trucking Pilot Program.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">TIME AND DATES:</HD>
          <P>The meeting will be held on Monday and Tuesday, June 20-21, 2011, from 8:30 a.m. to 4 p.m., Eastern Time (E.T.), and on Wednesday, June 22, from 8:30 a.m. to 1 p.m., E.T. The last hour of each day will be reserved for public comment.</P>
        </DATES>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Ms. Shannon L. Watson, Senior Adviser to the Associate Administrator for Policy, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590, (202) 385-2395,<E T="03">mcsac@dot.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <HD SOURCE="HD1">I. Background</HD>
        <HD SOURCE="HD2">MCSAC</HD>
        <P>Section 4144 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) (Pub. L. 109-59, 119 Stat. 1144, August 10, 2005) required the Secretary of Transportation to establish a Motor Carrier Safety Advisory Committee. The committee provides advice and recommendations to the FMCSA Administrator on motor carrier safety programs and regulations, and operates in accordance with the Federal Advisory Committee Act (5 U.S.C. App 2).</P>
        <HD SOURCE="HD2">Patterns of Safety Violations Task</HD>
        <P>SAFETEA-LU Section 4133 allows the Secretary to suspend, amend, or revoke any part of a motor carrier's registration if the Secretary finds that an officer of a motor carrier engages, or has engaged, in a pattern or practice of avoiding compliance, or masking or otherwise concealing noncompliance, with the Federal Motor Carrier Safety Regulations and Hazardous Materials Regulations, while serving as an officer of any motor carrier. The section defines an officer as “an owner, director, chief executive officer, chief financial officer, safety director, vehicle maintenance supervisor, and driver supervisor of a motor carrier, regardless of title attached to these functions, and any person, however designated, exercising controlling influence over the operations of a motor carrier.” Following deliberations of the Committee, the MCSAC will submit written recommendations in the form of a report to the FMCSA Administrator on this topic following its June 2011 meeting.</P>
        <HD SOURCE="HD2">Roadside Violation Severity Weightings Task</HD>

        <P>FMCSA's new compliance and enforcement program, Compliance, Safety, Accountability (CSA), includes a new measurement system to assess carriers' safety performance. One of the core purposes of the CSMS is to identify poor motor carrier safety behavior. Building upon FMCSA's previous Safety Status Measurement System (SafeStat), CSMS quantifies the on-road safety performance of carriers to identify candidates for interventions, determine the specific safety problems exhibited by a carrier and its drivers, and monitor whether safety problems are improving or worsening. FMCSA requests that<PRTPAGE P="32391"/>MCSAC provide the CSA team with its observations and recommendations regarding the violation groups and their associated crash risk by reviewing the tables of violation groups. The Committee will designate a subcommittee to address this task and subsequently report back to the full MCSAC.</P>
        <HD SOURCE="HD2">Long-Haul Cross Border Trucking Pilot Program Task</HD>
        <P>During the MCSAC's March 2011 meeting, FMCSA tasked the Committee with designating a subcommittee to provide independent monitoring for the program. The subcommittee would then report back to the full committee.</P>
        <HD SOURCE="HD1">II. Meeting Participation</HD>
        <P>Oral comments from the public will be heard during the last hour of each day of this meeting. Members of the public may submit written comments on this topic by Wednesday, June 15, 2011, to Federal Docket Management System (FDMS) Docket Number FMCSA-2006-26367 using any of the following methods:</P>
        <P>•<E T="03">Federal eRulemaking Portal:</E>Go to<E T="03">http://www.regulations.gov.</E>Follow the online instructions for submitting comments.</P>
        <P>•<E T="03">Fax:</E>202-493-2251.</P>
        <P>•<E T="03">Mail:</E>Docket Management Facility; U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building, Room WI2-140, Washington, DC 20590.</P>
        <P>•<E T="03">Hand Delivery:</E>U.S. Department of Transportation, 1200 New Jersey Avenue, SE., Room WI2-140, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.</P>
        <SIG>
          <DATED>Issued on: June 1, 2011.</DATED>
          <NAME>Larry W. Minor,</NAME>
          <TITLE>Associate Administrator for Policy.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13899 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
        <SUBAGY>Federal Railroad Administration</SUBAGY>
        <DEPDOC>[Docket No. FRA-2011-0027; Notice No. 1]</DEPDOC>
        <SUBJECT>Northeast Corridor Safety Committee; Notice of Meeting</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Federal Railroad Administration (FRA), Department of Transportation (DOT).</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Announcement of the Northeast Corridor Safety Committee Meeting.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>FRA announces the first meeting of the Northeast Corridor Safety Committee, a Federal advisory committee that is mandated by Section 212 of the Passenger Rail Investment and Improvement Act of 2008 (PRIIA). The Committee is made up of stakeholders operating on the Northeast Corridor, and the purpose of the Committee is to provide annual recommendations to the Secretary of Transportation.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>The meeting of the Northeast Corridor Safety Committee is scheduled to commence on Tuesday, June 14, 2011, at 9 a.m. and will adjourn by 3 p.m.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>The Northeast Corridor Safety Committee meeting will be held at the Crowne Plaza Washington National Airport, located at 1480 Crystal Drive in Arlington, VA. The meeting is open to the public on a first-come, first-served basis, and is accessible to individuals with disabilities. Sign and oral interpretation can be made available if requested 10 calendar days before the meeting.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Larry Woolverton, Northeast Corridor Committee Administrative Officer/Coordinator, FRA, 1200 New Jersey Avenue, SE., Mailstop 25, Washington, DC 20590, (202) 493-6212; or Mark McKeon, Special Assistant to the Associate Administrator for Railroad Safety/Chief Safety Officer, FRA, 1200 New Jersey Avenue, SE., Mailstop 25, Washington, DC 20590, (202) 493-6350.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P>The Northeast Corridor Safety Committee is mandated by a statutory provision in Section 212 of the PRIIA (codified at 49 U.S.C. 24905(f)). This Committee is chartered by the Secretary and is an official Federal Advisory Committee established in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. Title 5-Appendix.</P>
        <SIG>
          <DATED>Issued in Washington, DC, on June 1, 2011.</DATED>
          <NAME>Jo Strang,</NAME>
          <TITLE>Associate Administrator for Railroad Safety/Chief Safety Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13924 Filed 6-1-11; 4:15 pm]</FRDOC>
      <BILCOD>BILLING CODE 4910-06-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
        <SUBAGY>National Highway Traffic Safety Administration</SUBAGY>
        <DEPDOC>[Docket No. DOT-NHTSA-2011-0061, Notice 1]</DEPDOC>
        <SUBJECT>Notice of Receipt of Petition for Decision That Nonconforming 2007 Dodge Durango Multipurpose Passenger Vehicles Manufactured for the Mexican Market Are Eligible for Importation</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>National Highway Traffic Safety Administration, DOT.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice of receipt of petition.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2007 Dodge Durango multipurpose passenger vehicles (MPV) manufactured for the Mexican market (Mexican market 2007 Dodge Durango MPV), that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety Standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2007 Dodge Durango MPV,) and they are capable of being readily altered to conform to the standards.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>The closing date for comments on the petition is July 6, 2011.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:</P>
          <P>•<E T="03">Federal eRulemaking Portal:</E>Go to<E T="03">http://www.regulations.gov.</E>Follow the online instructions for submitting comments.</P>
          <P>•<E T="03">Mail:</E>Docket Management Facility: U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001</P>
          <P>•<E T="03">Hand Delivery or Courier:</E>West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. E.T., Monday through Friday, except Federal holidays.</P>
          <P>•<E T="03">Fax:</E>202-493-2251</P>
          <P>
            <E T="03">Instructions:</E>Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that<PRTPAGE P="32392"/>two copies are provided. If you wish to receive confirmation that your comments were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to<E T="03">http://www.regulations.gov,</E>including any personal information provided. Please see the Privacy Act heading below.</P>
          <P>
            <E T="03">Privacy Act:</E>Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union,<E T="03">etc.</E>). You may review DOT's complete Privacy Act Statement in the<E T="04">Federal Register</E>published on April 11, 2000 (65 FR 19477-78).</P>
          <P>
            <E T="03">How to Read Comments submitted to the Docket:</E>You may read the comments received by Docket Management at the address and times given above. You may also view the documents from the Internet at<E T="03">http://www.regulations.gov.</E>
          </P>
          <P>Follow the online instructions for accessing the dockets. The docket ID number and title of this notice are shown at the heading of this document notice. Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically search the Docket for new material.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Coleman Sachs, Office of Vehicle Safety Compliance, NHTSA (202-366-3151).</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>
        <HD SOURCE="HD1">Background</HD>
        <P>Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable FMVSS.</P>

        <P>Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice in the<E T="04">Federal Register</E>of each petition that it receives, and affords interested persons an opportunity to comment on the petition. At the close of the comment period, NHTSA decides, on the basis of the petition and any comments that it has received, whether the vehicle is eligible for importation. The agency then publishes this decision in the<E T="04">Federal Register</E>.</P>
        <P>Wallace Environmental Testing Laboratories, Inc. of Houston, Texas (WETL) (Registered Importer 90-005) has petitioned NHTSA to decide whether nonconforming Mexican market 2007 Dodge Durango MPV's are eligible for importation into the United States. The vehicles which WETL believes are substantially similar are 2007 Dodge Durango MPV's that were manufactured for sale in the United States and certified by their manufacturer as conforming to all applicable FMVSS.</P>
        <P>The petitioner claims that it carefully compared non-U.S. certified Mexican market 2007 Dodge Durango MPV's to their U.S.-certified counterparts, and found the vehicles to be substantially similar with respect to compliance with most FMVSS.</P>
        <P>WETL submitted information with its petition intended to demonstrate that non-U.S. certified Mexican market 2007 Dodge Durango MPV's, as originally manufactured, conform to many FMVSS in the same manner as their U.S. certified counterparts, or are capable of being readily altered to conform to those standards.</P>

        <P>Specifically, the petitioner claims that non-U.S. certified Mexican market 2007 Dodge Durango MPV's are identical to their U.S.-certified counterparts with respect to compliance with Standard Nos. 102<E T="03">Transmission Shift Lever Sequence, Starter Interlock, and Transmission Braking Effect,</E>103<E T="03">Windshield Defrosting and Defogging Systems,</E>104<E T="03">Windshield Wiping and Washing Systems,</E>106<E T="03">Brake Hoses,</E>108<E T="03">Lamps, Reflective Devices and Associated Equipment,</E>111<E T="03">Rearview Mirrors,</E>113<E T="03">Hood Latch System,</E>114<E T="03">Theft Protection,</E>116<E T="03">Motor Vehicle Brake Fluids,</E>118<E T="03">Power-Operated Window, Partition, and Roof Panel Systems,</E>120<E T="03">Tire Selection and Rims for Motor Vehicles Other than Passenger Cars,</E>124<E T="03">Accelerator Control Systems,</E>135<E T="03">Light Vehicle Brake Systems,</E>138<E T="03">Tire Pressure Monitoring Systems,</E>201<E T="03">Occupant Protection in Interior Impact,</E>202<E T="03">Head Restraints,</E>204<E T="03">Steering Control Rearward Displacement,</E>205<E T="03">Glazing Materials,</E>206<E T="03">Door Locks and Door Retention Components,</E>207<E T="03">Seating Systems,</E>208<E T="03">Occupant Crash Protection</E>209<E T="03">Seat Belt Assemblies,</E>210<E T="03">Seat Belt Assembly Anchorages,</E>212<E T="03">Windshield Mounting,</E>214<E T="03">Side Impact Protection,</E>216<E T="03">Roof Crush Resistance,</E>219<E T="03">Windshield Zone Intrusion,</E>301<E T="03">Fuel System Integrity,</E>and 302<E T="03">Flammability of Interior Materials.</E>
        </P>
        <P>Petitioner also contends that the vehicle is capable of being readily altered to meet the following standards, in the manner indicated:</P>
        <P>Standard No. 101<E T="03">Controls and Displays:</E>inscription of the word “brake” on the instrument cluster in place of the international ECE warning symbol.</P>
        <P>Standard No. 225<E T="03">Child Restraint Anchorage Systems:</E>inspection of all vehicles and installation of U.S.-model child restraint anchorage system components on vehicles not already so equipped to ensure that the child restraint anchorage system meets the requirements of this standard.</P>
        <P>The petitioner additionally states that a vehicle identification plate must be affixed to the vehicles near the left windshield post to meet the requirements of 49 CFR Part 565.</P>

        <P>All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the<E T="04">Federal Register</E>pursuant to the authority indicated below.</P>
        <AUTH>
          <HD SOURCE="HED">Authority:</HD>
          <P>49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8; delegations of authority at 49 CFR 1.50 and 501.8.</P>
        </AUTH>
        <SIG>
          <DATED>Issued on: May 31, 2011.</DATED>
          <NAME>Claude H. Harris,</NAME>
          <TITLE>Director, Office of Vehicle Safety Compliance.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13888 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4910-59-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Community Development Financial Institutions Fund</SUBAGY>
        <SUBJECT>Notice of Allocation Availability (NOAA) Inviting Applications for the CY 2011 Allocation Round of the New Markets Tax Credit Program</SUBJECT>
        <P>
          <E T="03">Announcement Type:</E>Initial announcement of tax credit allocation availability.</P>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>

          <P>Electronic applications must be received by 5 p.m. ET on July 27, 2011. Applications sent by mail, facsimile or other form will not be accepted. Please note the Community Development Financial Institutions Fund (the CDFI Fund) will only accept applications and attachments (<E T="03">i.e.,</E>the CDE's authorized<PRTPAGE P="32393"/>representative signature page, the Controlling Entity's representative signature page, investor letters and organizational charts) in electronic form (see Section IV.D. of this NOAA for more details). Applications must meet all eligibility and other requirements and deadlines, as applicable, set forth in this NOAA. Allocation applicants that are not yet certified as Community Development Entities (CDEs) must submit an application for certification as a CDE that is postmarked on or before June 22, 2011 (see Section III of this NOAA for more details).</P>
          <P>
            <E T="03">Executive Summary:</E>This NOAA is issued in connection with the calendar year 2011 tax credit allocation round of the New Markets Tax Credit (NMTC) Program, as initially authorized by Title I, subtitle C, section 121 of the Community Renewal Tax Relief Act of 2000 (Pub. L. 106-554) and amended by section 221 of the American Jobs Creation Act of 2004 (Pub. L. 108-357), section 101 of the Gulf Opportunity Zone Act of 2005 (Pub. L. 108-357), Division A, section 102 of the Tax Relief and Health Care Act of 2006 (Pub. L. 109-432), and section 733 of the Tax Relief, Unemployment Insurance Reauthorization and Job Creation Act of 2010 (the Act). Through the NMTC Program, the CDFI Fund provides authority to CDEs to offer an incentive to investors in the form of tax credits over seven years, which is expected to stimulate the provision of private investment capital that, in turn, will facilitate economic and community development in Low-Income Communities. Through this NOAA, the CDFI Fund announces the availability of up to $3.5 billion of NMTC authority authorized by the Act.</P>
          <P>In this NOAA, the CDFI Fund specifically addresses how an entity may apply to receive an allocation of NMTCs, the competitive procedure through which NMTC Allocations will be made, and the actions that will be taken to ensure that proper allocations are made to appropriate entities.</P>
        </DATES>
        <HD SOURCE="HD1">I. Allocation Availability Description</HD>
        <HD SOURCE="HD2">A. Programmatic changes:</HD>
        <P>1.<E T="03">Allocation Amounts:</E>As described in Section IIA, the CDFI Fund anticipates that it will provide allocation awards of not more than $125 million per applicant.</P>
        <P>2.<E T="03">Prior QEI Issuance Requirements:</E>In order to be eligible to apply for NMTC allocations in the CY2011 round, as described in Section III.A.2(a), applicants that have received NMTC allocation awards in previous rounds are required to meet minimum Qualified Equity Investment (QEI) issuance thresholds with respect to their prior-year allocations. These thresholds have been revised in comparison to the 2010 NOAA.</P>
        <P>3.<E T="03">Healthy Food Financing Initiative:</E>The United States Department of Agriculture (USDA), Health and Human Services (HHS), and the United States Department of Treasury are working together to support projects that increase access to healthy, affordable food in “food deserts”—low-income neighborhoods that lack access to healthy food options. As part of a coordinated effort called the Healthy Food Financing Initiative (HFFI), these three departments will aim to expand the availability of nutritious food through the establishment of healthy food retail outlets, including developing and equipping grocery stores, small retailers, corner stores, and farmers markets to help revitalize neighborhoods that currently lack these options.</P>
        <P>The NMTC Program is one of several programs that have been identified as part of the HFFI. To this end, under the 2011 NMTC application round, the CDFI Fund will collect information from applicants regarding the extent to which they intend to use NMTCs in support of healthy food financing in food deserts. However, the extent to which an applicant intends to provide healthy food financing will not be a factor in the scoring or selection process. This information will be gathered for informational purposes only, as a means to identify NMTC awardees that may finance these types of activities going forward and to track the outcomes of these investments.</P>
        <P>B.<E T="03">Program guidance and regulations:</E>This NOAA provides guidance for the application and allocation of NMTCs for the ninth round of the NMTC Program and should be read in conjunction with: (i) Guidance published by the CDFI Fund on how an entity may apply to become certified as a CDE (66<E T="03">FR</E>65806, December 20, 2001); (ii) the final regulations issued by the Internal Revenue Service (26 CFR 1.45D-1, published on December 28, 2004) and related guidance, notices and other publications; and (iii) the application and related materials for this ninth NMTC Program allocation round. All such materials may be found on the CDFI Fund's Web site at<E T="03">http://www.cdfifund.gov.</E>The CDFI Fund encourages applicants to review these documents. Capitalized terms used, but not defined, in this NOAA shall have the respective meanings assigned to them in the allocation application, IRC § 45D or the IRS regulations.</P>
        <HD SOURCE="HD1">II. Allocation Information</HD>
        <P>A.<E T="03">Allocation amounts:</E>Pursuant to the Act, the CDFI Fund expects that it may allocate to CDEs the authority to issue to their investors up to the aggregate amount of $3.5 billion in equity as to which NMTCs may be claimed, as permitted under IRC § 45D(f)(1)(D). Pursuant to this NOAA, the CDFI Fund anticipates that it will not issue more than $125 million in tax credit allocation authority per applicant. The CDFI Fund, in its sole discretion, reserves the right to allocate amounts in excess of or less than the anticipated maximum allocation amount should the CDFI Fund deem it appropriate. In order to receive an allocation in excess of the $125 million cap, an applicant, at a minimum, will need to demonstrate that: (i) No part of its strategy can be successfully implemented without an allocation in excess of the applicable cap; and/or (ii) its strategy will produce extraordinary community impact. The CDFI Fund reserves the right to allocate tax credit authority to any, all, or none of the entities that submit an application in response to this NOAA, and in any amount it deems appropriate.</P>
        <P>B.<E T="03">Types of awards:</E>NMTC Program awards are made in the form of tax credit authority.</P>
        <P>C.<E T="03">Allocation Agreement:</E>Each Allocatee under this NOAA must sign an Allocation Agreement, which must be countersigned by the CDFI Fund, before the NMTC Allocation is effective. The Allocation Agreement contains the terms and conditions of the allocation. For further information, see Section VI of this NOAA.</P>
        <HD SOURCE="HD1">III. Eligibility</HD>
        <P>A.<E T="03">Eligible applicants:</E>IRC § 45D specifies certain eligibility requirements that each applicant must meet to be eligible to apply for an allocation of NMTCs. The following sets forth additional detail and certain additional dates that relate to the submission of applications under this NOAA for the $3.5 billion in general NMTC allocation authority.</P>
        <P>1.<E T="03">CDE certification:</E>For purposes of this NOAA, the CDFI Fund will not consider an application for an allocation of NMTCs unless: (a) The applicant is certified as a CDE at the time the CDFI Fund receives its NMTC Program allocation application; or (b) the applicant submits an application for certification as a CDE that is postmarked on or before June 22, 2011. Applicants for certification may obtain a CDE certification application through the CDFI Fund's Web site at<E T="03">http://www.cdfifund.gov.</E>Applications for CDE<PRTPAGE P="32394"/>certification must be submitted as instructed in the application form. An applicant that is a community development financial institution (CDFI) or a specialized small business investment company (SSBIC) does not need to submit a CDE certification application; however, it must register as a CDE on the CDFI Fund's Web site on or before 5 p.m. ET on June 22, 2011.</P>
        <P>The CDFI Fund will not provide allocations of NMTCs to applicants that are not certified as CDEs. See Section IV.D.1.(c) of this NOAA for further requirements relating to postmarks.</P>

        <P>If an applicant that has already been certified as a CDE wishes to change its designated CDE service area, it must submit its request for such a change to the CDFI Fund; and the request must be received by the CDFI Fund by 5 p.m. ET on June 22, 2011. The CDE service area change request must be sent from the applicant's authorized representative and include the applicable CDE control number, the revised service area designation, and an updated accountability chart that reflects representation from Low-Income Communities in the revised service area. The service area change request must be sent by e-mail to<E T="03">ccme@cdfi.treas.gov</E>or by facsimile to (202) 622-7754.</P>
        <P>2.<E T="03">Prior awardees or Allocatees:</E>Applicants must be aware that success in a prior round of any of the CDFI Fund's programs is not indicative of success under this NOAA. For purposes of this section, the CDFI Fund will consider an Affiliate to be any entity that meets the definition of Affiliate as defined in the NMTC allocation application materials, or any entity otherwise identified as an Affiliate by the applicant in its NMTC allocation application materials. Prior awardees of any CDFI Fund Program are eligible to apply under this NOAA, except as follows:</P>
        <P>(a)<E T="03">Prior Allocatees and Qualified Equity Investment (QEI) issuance requirements:</E>The following describes the QEI issuance requirements applicable to prior Allocatees.</P>
        <P>A prior Allocatee in the CY 2005 round of the NMTC Program is not eligible to receive a NMTC Allocation pursuant to this NOAA unless the Allocatee is able to affirmatively demonstrate that, as of 11:59 p.m. ET on October 14, 2011, it has issued and received funds in-hand (the term “funds in-hand” does not include committed funding) from its investors for 95 percent of its QEIs relating to its CY 2005 NMTC Allocation.</P>
        <P>A prior Allocatee in the CY 2006 round of the NMTC Program is not eligible to receive a NMTC Allocation pursuant to this NOAA unless the Allocatee is able to affirmatively demonstrate that, as of 11:59 p.m. ET on October 14, 2011, it has: (i) Issued and received funds in-hand from its investors for at least 80 percent of its QEIs relating to its CY 2006 NMTC Allocation; or (ii) issued and received funds in-hand from its investors for at least 60 percent of its QEIs and that 100 percent of its total CY 2006 NMTC Allocation has been exchanged for funds in-hand from investors, or has been committed by its investors.</P>
        <P>A prior Allocatee in the CY 2007 round of the NMTC Program is not eligible to receive a NMTC Allocation pursuant to this NOAA unless the Allocatee is able to affirmatively demonstrate that, as of 11:59 p.m. ET on October 14, 2011, it has: (i) Issued and received funds in-hand from its investors for at least 60 percent of its QEIs relating to its CY 2007 NMTC Allocation; or (ii) issued and received funds in-hand from its investors for at least 50 percent of its QEIs and that at least 80 percent of its total CY 2007 NMTC Allocation has been exchanged for funds in-hand from investors, or has been committed by its investors.</P>
        <P>A prior Allocatee in the CY 2008 round of the NMTC Program is not eligible to receive a NMTC Allocation pursuant to this NOAA unless the Allocatee is able to affirmatively demonstrate that, as of 11:59 p.m. ET on October 14, 2011, it has: (i) Issued and received funds in-hand from its investors for at least 50 percent of its QEIs relating to its CY 2008 NMTC Allocation; or (ii) issued and received funds in-hand from its investors for at least 40 percent of its QEIs and that at least 80 percent of its total CY 2008 NMTC Allocation has been exchanged for funds in-hand from investors, or has been committed by its investors.</P>
        <P>A prior Allocatee (with the exception of a Rural CDE Allocatee) in the CY 2009 round of the NMTC Program is not eligible to receive a NMTC Allocation pursuant to this NOAA unless the Allocatee is able to affirmatively demonstrate that, as of 11:59 p.m. ET on October 14, 2011, it has: (i) Issued and received funds in-hand from its investors for at least 30 percent of its QEIs relating to its CY 2009 NMTC Allocation; or (ii) issued and received funds in-hand from its investors for at least 20 percent of its QEIs and that at least 60 percent of its total CY 2008 NMTC Allocation has been exchanged for funds in-hand from investors, or has been committed by its investors. A prior Rural CDE Allocatee in the CY 2009 is not eligible to receive a NMTC Allocation pursuant to this NOAA unless the Allocatee can demonstrate that, as of 11:59 p.m. ET on October 14, 2011, it has: (i) Issued and received funds in-hand from its investors for at least 20 percent of its QEIs relating to its CY 2008 NMTC Allocation.</P>
        <P>A prior Allocatee (with the exception of a Rural CDE Allocatee) in the CY 2010 round of the NMTC Program is not eligible to receive a NMTC Allocation pursuant to this NOAA unless the Allocatee is able to affirmatively demonstrate that, as of 11:59 p.m. ET on October 14, 2011, it has: (i) Issued and received funds in-hand from its investors for at least 20 percent of its QEIs relating to its CY 2010 NMTC Allocation; or (ii) issued and received funds in-hand from its investors for at least 10 percent of its QEIs and that at least 30 percent of its total CY 2010 NMTC Allocation has been exchanged for funds in-hand from investors, or has been committed by its investors. A Rural CDE is not required to meet the above QEI issuance and commitment thresholds with regard to its CY 2010 NMTC allocation award.</P>
        <P>In addition to the requirements described above, an entity is not eligible to receive a NMTC Allocation pursuant to this NOAA if an Affiliate of the applicant is a prior Allocatee and has not met the requirements for the issuance and/or commitment of QEIs as set forth above for the Allocatees in the prior allocation rounds of the NMTC Program.</P>
        <P>Notwithstanding the above, if an applicant has received multiple NMTC allocation awards between the CY 2005 and the CY 2010, the applicant shall be deemed to be eligible to apply for a NMTC Allocation pursuant to this NOAA if the applicant is able to affirmatively demonstrate that, as of 11:59 p.m. ET on October 14, 2011, it has issued and received funds in-hand from its investors for at least 70 percent of its QEIs relating to its cumulative allocation amounts from these prior NMTC Program rounds. Rural CDEs that received allocations under the CY 2009 round may choose to exclude such allocations from this cumulative calculation, provided that the Allocatee has issued and received funds in-hand from its investors for at least 20 percent of its QEIs relating to its CY 2009 allocation. Rural CDEs that received allocations under the CY2010 round may choose to exclude such allocation from this cumulative calculation.</P>

        <P>For purposes of this section of the NOAA, the CDFI Fund will only recognize as “issued” those QEIs that have been finalized in the CDFI Fund's Allocation Tracking System (ATS) by the deadlines specified above.<PRTPAGE P="32395"/>Allocatees and their Subsidiary transferees, if any, are advised to access ATS to record each QEI that they issue to an investor in exchange for funds in-hand. For purposes of this section of the NOAA, “committed” QEIs are only those Equity Investments that are evidenced by a written, signed document in which an investor: (i) Commits to make an investment in the Allocatee in a specified amount and on specified terms; (ii) has made an initial disbursement of the investment proceeds to the Allocatee, and such initial disbursement has been recorded in ATS as a QEI; (iii) commits to disburse the remaining investment proceeds to the Allocatee based on specified amounts and payment dates; and (iv) commits to make the final disbursement to the Allocatee no later than October 14, 2013.</P>
        <P>The applicant will be required, upon notification from the CDFI Fund, to submit adequate documentation to substantiate the required issuances of and commitments for QEIs.</P>
        <P>Applicants should be aware that these QEI issuance requirements represent the minimum threshold requirements that must be met in order to submit an application for assistance under this NOAA. As stated in Section V.B.2 of this NOAA, the CDFI Fund reserves the right to reject an application and/or adjust award amounts as appropriate based on information obtained during the review process—including an applicant's track record of raising QEIs and/or deploying its QLICIs.</P>

        <P>Prior Allocatees that require any action by the CDFI Fund (i.e., certifying a subsidiary entity as a CDE; adding a subsidiary CDE to an Allocation Agreement; etc.) in order to meet the QEI issuance requirements above must submit their Certification Application for subsidiary CDEs by no later than July 8, 2011 and Allocation Agreement Amendment requests by no later than September 13, 2011 in order to guarantee that the CDFI Fund completes all necessary approvals prior to October 14, 2011. Applicants for certification may obtain a CDE certification application through the CDFI Fund's Web site at<E T="03">http://www.cdfifund.gov.</E>Applications for CDE certification must be submitted as instructed in the application form.</P>
        <P>(b)<E T="03">Failure to meet reporting requirements:</E>The CDFI Fund will not consider an application submitted by an applicant if the applicant or any of its Affiliates is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program and is not current on the reporting requirements set forth in a previously executed assistance, allocation or award agreement(s), as of the application deadline of this NOAA. Please note that the CDFI Fund only acknowledges the receipt of reports that are complete. As such, incomplete reports or reports that are deficient of required elements will not be recognized as having been received.</P>
        <P>(c)<E T="03">Pending resolution of noncompliance:</E>If an applicant is a prior awardee or Allocatee under any CDFI Fund program and if: (i) It has submitted complete and timely reports to the CDFI Fund that demonstrate noncompliance with a previous assistance, award or Allocation Agreement; and (ii) the CDFI Fund has yet to make a final determination as to whether the entity is in default of its previous assistance, award or Allocation Agreement, the CDFI Fund will consider the applicant's application under this NOAA pending full resolution of the noncompliance, in the sole determination of the CDFI Fund. Further, if an Affiliate of the applicant is a prior CDFI Fund awardee or Allocatee and if such entity: (i) Has submitted complete and timely reports to the CDFI Fund that demonstrate noncompliance with a previous assistance, award or Allocation Agreement; and (ii) the CDFI Fund has yet to make a final determination as to whether the entity is in default of its previous assistance, award or Allocation Agreement, the CDFI Fund will consider the applicant's application under this NOAA pending full resolution of the noncompliance, in the sole determination of the CDFI Fund.</P>
        <P>(d)<E T="03">Default status:</E>The CDFI Fund will not consider an application submitted by an applicant that is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program if, as of the application deadline of this NOAA, the CDFI Fund has made a final determination that such applicant is in default of a previously executed assistance, allocation or award agreement(s) and the CDFI Fund has provided written notification of such determination to such applicant.</P>
        <P>Further, an entity is not eligible to apply for an allocation pursuant to this NOAA if, as of the application deadline of this NOAA, the CDFI Fund has made a final determination that an Affiliate of the applicant is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program and has been determined by the CDFI Fund to be in default of a previously executed assistance, allocation or award agreement(s) and the CDFI Fund has provided written notification of such determination. Such entities will be ineligible to apply for an award pursuant to this NOAA so long as the Applicant's, or its Affiliate's, prior award or allocation remains in default status or such other time period as specified by the CDFI Fund in writing.</P>
        <P>(e)<E T="03">Termination in default:</E>The CDFI Fund will not consider an application submitted by an applicant that is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program if: (i) Within the 12-month period prior to the application deadline of this NOAA, the CDFI Fund has made a final determination that such applicant's prior award or allocation terminated in default of a previously executed assistance, allocation or award agreement(s); (ii) the CDFI Fund has provided written notification of such determination to such applicant; and (iii) the final reporting period end date for the applicable terminated assistance, allocation or award agreement(s) falls within the 12-month period prior to the application deadline of this NOFA.</P>
        <P>Further, an entity is not eligible to apply for an allocation pursuant to this NOAA if: (i) Within the 12-month period prior to the application deadline of this NOAA, the CDFI Fund has made a final determination that an Affiliate of the applicant is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program whose award or allocation terminated in default of a previously executed assistance, allocation or award agreement(s); (ii) the CDFI Fund has provided written notification of such determination to the defaulting entity; and (iii) the final reporting period end date for the applicable terminated assistance, allocation or award agreement(s) falls within the 12-month period prior to the application deadline of this NOAA.</P>
        <P>(f)<E T="03">Undisbursed award funds:</E>The CDFI Fund will not consider an application submitted by an Applicant that is a prior CDFI Fund Awardee under any CDFI Fund program if the Applicant has a balance of undisbursed award funds (defined below) under said prior award(s), as of the applicable application deadline of this NOAA. Furthermore, an entity is not eligible to apply for an award pursuant to this NOAA if an Affiliate of the applicant is a prior CDFI Fund Awardee under any CDFI Fund program, and has a balance of undisbursed award funds under said prior award(s), as of the applicable application deadline of this NOAA. In a case where an Affiliate of the applicant is a prior CDFI Fund Awardee under any CDFI Fund program and has a balance of undisbursed award funds under said prior award(s) as of the applicable application deadline of this NOAA, the CDFI Fund will include the combined awards of the Applicant and<PRTPAGE P="32396"/>such Affiliated entities when calculating the amount of undisbursed award funds.</P>
        <P>For purposes of the calculation of undisbursed award funds for the BEA Program, only awards made to the Applicant (and any Affiliates) three to five calendar years prior to the end of the calendar year of the application deadline of this NOAA are included (“includable BEA awards”). Thus, for purposes of this NOAA, undisbursed BEA Program award funds are the amount of FYs 2006, 2007 and 2008 awards that remain undisbursed as of the application deadline of this NOAA.</P>
        <P>For purposes of the calculation of undisbursed award funds for the CDFI Program and the Native Initiatives Funding Programs, only awards made to the Applicant (and any entity that Controls the Applicant, is Controlled by the Applicant or shares common management officials with the Applicant, as determined by the CDFI Fund) two to five calendar years prior to the end of the calendar year of the application deadline of this NOAA are included (“includable CDFI/NI awards”). Thus, for purposes of this NOAA, undisbursed CDFI Program and Native Initiative (NI) awards are the amount of FYs 2006, 2007, 2008 and 2009 awards that remain undisbursed as of the application deadline of this NOAA.</P>
        <P>To calculate total includable BEA/CDFI/NI awards: Amounts that are undisbursed as of the application deadline of this NOAA cannot exceed five percent (5%) of the total includable awards. Please refer to an example of this calculation in the 2011 Allocation Application Q&amp;A document, available on the CDFI Fund's Web site.</P>
        <P>The “undisbursed award funds” calculation does not include: (i) Tax credit allocation authority made available through the New Market Tax Credit (NMTC) Program; (ii) any award funds for which the CDFI Fund received a full and complete disbursement request from the Awardee by the applicable application deadline of this NOAA; (iii) any award funds for an award that has been terminated, in writing, by the CDFI Fund or deobligated by the CDFI Fund; or (iv) any award funds for an award that does not have a fully executed assistance or award agreement. The CDFI Fund strongly encourages Applicants requesting disbursements of “undisbursed funds” from prior awards to provide the CDFI Fund with a complete disbursement request at least 30 business days prior to the application deadline of this NOAA.</P>
        <P>(g)<E T="03">Contact the CDFI Fund:</E>Accordingly, Applicants that are prior awardees and/or Allocatees under any other CDFI Fund program are advised to: (i) Comply with the requirements specified in assistance, allocation and/or award agreement(s), and (ii) contact the CDFI Fund to ensure that all necessary actions are underway for the disbursement of any outstanding balance of a prior award(s). All outstanding reports and compliance questions should be directed to the Compliance Manager by e-mail at<E T="03">cme@cdfi.treas.gov,</E>by telephone at (202) 622-6330, or by facsimile at (202) 622-7754. All disbursement questions should be directed to the CDFI Fund's Senior Resource Manager by telephone at (202) 622-7165 or by facsimile at (202) 622-7754. Requests submitted less than thirty calendar days prior to the application deadline may not receive a response before the application deadline.</P>
        <P>Both the Compliance Manager and the Senior Resource Manager may be reached by mail at CDFI Fund, 601 13th Street, NW., Suite 200 South, Washington, DC 20005.</P>
        <P>The CDFI Fund will respond to Applicants' reporting, compliance or disbursement questions between the hours of 9 a.m. and 5 p.m. ET, starting on  the date of publication of this NOAA through July 25, 2011 (two days before the application deadline). The CDFI Fund will not respond to Applicants' reporting, compliance or disbursement phone calls or e-mail inquiries that are received after 5 p.m. ET on July 25, 2011 until after the funding application deadline of July 27, 2011.</P>
        <P>3.<E T="03">Entities that propose to transfer NMTCs to Subsidiaries:</E>Both for-profit and non-profit CDEs may apply to the CDFI Fund for allocations of NMTCs, but only a for-profit CDE is permitted to provide NMTCs to its investors. A non-profit applicant wishing to apply for a NMTC Allocation must demonstrate, prior to entering into an Allocation Agreement with the CDFI Fund, that: (i) It controls one or more Subsidiaries that are for-profit entities; and (ii) it intends to transfer the full amount of any NMTC Allocation it receives to said Subsidiary.</P>
        <P>An applicant wishing to transfer all or a portion of its NMTC Allocation to a Subsidiary is not required to create the Subsidiary prior to submitting a NMTC allocation application to the CDFI Fund. However, the Subsidiary entities must be certified as CDEs by the CDFI Fund, and enjoined as parties to the Allocation Agreement at closing or by amendment to the Allocation Agreement after closing. Before the NMTC Allocation transfer may occur it must be pre-approved by the CDFI Fund, in its sole discretion.</P>
        <P>The CDFI Fund strongly encourages a non-profit applicant to submit a CDE certification application to the CDFI Fund on behalf of the Subsidiary within 60 days after the non-profit applicant receives the draft Allocation Agreement from the CDFI Fund; as such Subsidiary must be certified as a CDE prior to entering into an Allocation Agreement with the CDFI Fund. A non-profit applicant that fails to certify one or more for-profit subsidiaries within 60 days of receiving the draft Allocation Agreement from the CDFI Fund is subject to the CDFI Fund rescinding the award.</P>
        <P>4.<E T="03">Entities that submit applications together with Affiliates; applications from common enterprises:</E>(a) As part of the allocation application review process, the CDFI Fund considers whether applicants are Affiliates, as such term is defined in the allocation application. If an applicant and its Affiliates wish to submit allocation applications, they must do so collectively, in one application; an applicant and its Affiliates may not submit separate allocation applications. If Affiliated entities submit multiple applications, the CDFI Fund reserves the right either to reject all such applications received or to select a single application as the only application considered for an allocation. In the case of governmental entities, the CDFI Fund may accept applications submitted by Affiliated entities, but only to the extent the CDFI Fund determines that the business strategies and/or activities described in such applications, submitted by separate entities, are distinctly dissimilar and are operated and/or managed by distinctly dissimilar boards and staff, including identified consultants. In such cases, the CDFI Fund reserves the right to limit award amounts to such entities to ensure that the entities do not collectively receive more than the $125 million cap.</P>

        <P>For purposes of this NOAA, in addition to assessing whether applicants meet the definition of the term “Affiliate” found in the allocation application, the CDFI Fund will consider: (i) Whether the activities described in applications submitted by separate entities are, or will be, operated and/or managed as a common enterprise that, in fact or effect, may be viewed as a single entity; (ii) whether the applications submitted by separate entities contain significant narrative, textual or other similarities, and (iii) whether the business strategies and/or activities described in applications submitted by separate entities are so closely related, in fact or effect, they<PRTPAGE P="32397"/>may be viewed as substantially identical applications. In such cases, the CDFI Fund reserves the right either to reject all applications received from all such entities; to select a single application as the only one that will be considered for an allocation; and, in the event that an Application is selected to receive an allocation award, to deem certain activities ineligible. These requirements shall apply to all applicants, including those that are Affiliated with governmental entities.</P>

        <P>(b) Furthermore, an applicant that receives an allocation in this allocation round (or its Subsidiary transferee) may not become an Affiliate of or member of a common enterprise (as defined above) with another applicant that receives an allocation in this allocation round (or its Subsidiary transferee) at any time after the submission of an allocation application under this NOAA. This prohibition, however, generally does not apply to entities that are commonly Controlled solely because of common ownership by QEI investors. This requirement will also be a term and condition of the Allocation Agreement (see Section VI.B. of this NOAA and additional application guidance materials on the CDFI Fund's Web site at<E T="03">http://www.cdfifund.gov</E>for more details).</P>
        <P>5.<E T="03">Entities created as a series of funds:</E>An applicant whose business structure consists of an entity with a series of funds may apply for CDE certification as a single entity, or as multiple entities. If such an applicant represents that it is properly classified for Federal tax purposes as a single partnership or corporation, it may apply for CDE certification as a single entity. If an applicant represents that it is properly classified for Federal tax purposes as multiple partnerships or corporations, then it may submit a single CDE certification application on behalf of the entire series of funds, and each fund must be separately certified as a CDE. Applicants should note, however, that receipt of CDE certification as a single entity or as multiple entities is not a determination that an applicant and its related funds are properly classified as a single entity or as multiple entities for Federal tax purposes. Regardless of whether the series of funds is classified as a single partnership or corporation or as multiple partnerships or corporations, an applicant may not transfer any NMTC Allocations it receives to one or more of its funds unless the transfer is pre-approved by the CDFI Fund, in its sole discretion, which will be a condition of the Allocation Agreement.</P>
        <P>6.<E T="03">Entities that are BEA Program awardees:</E>An insured depository institution investor (and its Affiliates and Subsidiaries) may not receive a NMTC Allocation in addition to a BEA Program award for the same investment in a CDE. Likewise, an insured depository institution investor (and its Affiliates and Subsidiaries) may not receive a BEA Program award in addition to a NMTC Allocation for the same investment in a CDE.</P>
        <HD SOURCE="HD1">IV. Application and Submission Information</HD>
        <P>A.<E T="03">Address to request application package:</E>Applicants must submit applications electronically under this NOAA, through the CDFI Fund Web site. Following the publication of this NOAA, the CDFI Fund will make the electronic allocation application available on its Web site at<E T="03">http://www.cdfifund.gov.</E>Applications sent by mail, facsimile or other form will not be accepted. Please note the CDFI Fund will only accept the application and attachments (<E T="03">i.e.</E>the Applicant's authorized representative signature page, the Controlling Entity's representative signature page, investor letters and organizational charts) in electronic form.</P>
        <P>B.<E T="03">Application content requirements:</E>Detailed application content requirements are found in the application related to this NOAA. Applicants must submit all materials described in and required by the application by the applicable deadlines. Applicants will not be afforded an opportunity to provide any missing materials or documentation. Electronic applications must be submitted solely by using the format made available at the CDFI Fund's Web site. Additional information, including instructions relating to the submission of supporting information (<E T="03">i.e.,</E>the Applicant's authorized representative signature page, the Controlling Entity's representative signature page, investor letters and organizational charts), is set forth in further detail in the electronic application. An application must include a valid and current Employer Identification Number (EIN) issued by the Internal Revenue Service and assigned to the applicant and, if applicable, it's Controlling Entity. Electronic applications without a valid EIN are incomplete and cannot be transmitted to the CDFI Fund. For more information on obtaining an EIN, please contact the Internal Revenue Service at (800) 829-4933 or<E T="03">http://www.irs.gov.</E>
        </P>
        <P>An applicant may not submit more than one application in response to this NOAA. In addition, as stated in Section III.A.4 of this NOAA, an applicant and its Affiliates must collectively submit only one allocation application; an applicant and its Affiliates may not submit separate allocation applications except as outlined above. Once an application is submitted, an applicant will not be allowed to change any element of its application.</P>
        <P>C.<E T="03">Form of application submission:</E>Applicants may only submit applications under this NOAA electronically. Applications sent by facsimile or by e-mail will not be accepted. Submission of an electronic application will facilitate the processing and review of applications and the selection of Allocatees; further, it will assist the CDFI Fund in the implementation of electronic reporting requirements.</P>
        <P>1.<E T="03">Electronic applications:</E>Electronic applications must be submitted solely by using the CDFI Fund's Web site and must be sent in accordance with the submission instructions provided in the electronic application form. The CDFI Fund recommends use of Internet Explorer version 8 on Windows XP, and optimally at least a 56Kbps Internet connection in order to meet the electronic application submission requirements. Use of other browsers (<E T="03">i.e.,</E>Firefox), other versions of Internet Explorer, or other systems (<E T="03">i.e.,</E>Mac) might result in problems during submission of the application. The CDFI Fund's electronic application system will only permit the submission of applications in which all required questions and tables are fully completed. Additional information, including instructions relating to the submission of supporting information (<E T="03">i.e.,</E>the applicant's authorized representative signature page, the Controlling Entity's representative signature page, investor letters and organizational charts) is set forth in further detail in the electronic application.</P>
        <P>D.<E T="03">Application submission dates and times:</E>
        </P>
        <P>1.<E T="03">Application deadlines:</E>
        </P>
        <P>(a)<E T="03">Electronic applications:</E>must be received by 5 p.m. ET on July 27, 2011. Electronic applications cannot be transmitted or received after 5 p.m. ET on July 27, 2011. In addition, applicants that submit electronic applications must separately submit supporting information (<E T="03">i.e.,</E>the applicant's authorized representative signature page, the Controlling Entity's representative signature page, investor letters and organizational charts) via their myCDFIFund account. The applicant's authorized representative signature page, the Controlling Entity's<PRTPAGE P="32398"/>representative signature page, investor letters and organizational charts must be submitted on or before 11:59 p.m. ET on July 29, 2011. The CDFI Fund recommends that attachments have a size limit of 5 megabytes (MB). See application instructions, provided in the electronic application and the 2011 Allocation Application Q&amp;A, for further detail. Applications and other required documents received after this date and time will be rejected. If the applicant's authorized representative signature page is not received by the deadline specified above, the CDFI Fund reserves the right to reject the application. Please note that the document submission deadlines in this NOAA and/or the allocation application are strictly enforced.</P>
        <P>(b)<E T="03">Postmark:</E>For purposes of this NOAA, the term “postmark” is defined by 26 CFR 301.7502-1. In general, the CDFI Fund will require that the postmarked document bears a postmark date that is on or before the applicable deadline. The document must be in an envelope or other appropriate wrapper, properly addressed as set forth in this NOAA and delivered by the United States Postal Service or any other private delivery service designated by the Secretary of the Treasury. For more information on designated delivery services, please see IRS Notice 2002-62, 2002-2 C.B. 574.</P>
        <P>E.<E T="03">Intergovernmental Review:</E>Not applicable.</P>
        <P>F.<E T="03">Funding Restrictions:</E>For allowable uses of investment proceeds related to a NMTC Allocation, please see 26 U.S.C. 45D and the final regulations issued by the Internal Revenue Service (26 CFR 1.45D-1, published December 28, 2004) and related guidance. Please see Section I, above, for the Programmatic Changes of this NOAA.</P>
        <P>G.<E T="03">Paperwork Reduction:</E>Under the Paperwork Reduction Act (44 U.S.C. chapter 35), an agency may not conduct or sponsor a collection of information, and an individual is not required to respond to a collection of information, unless it displays a valid OMB control number. Pursuant to the Paperwork Reduction Act, the application has been assigned the following control number: 1559-0016.</P>
        <HD SOURCE="HD1">V. Application Review Information</HD>
        <P>There are two parts to the substantive review process for each allocation application: Phase 1 and Phase 2. In Phase 1, the CDFI Fund will evaluate each application, assigning points and numeric scores according to the criteria described below. In Phase 2, the CDFI Fund will rank applicants in accordance with the procedures set forth below.</P>
        <P>A.<E T="03">Criteria:</E>
        </P>
        <P>1.<E T="03">Business Strategy</E>(25-point maximum): (a) When assessing an applicant's business strategy, reviewers will consider, among other things: the applicant's products, services and investment criteria; the prior performance of the applicant or its Controlling Entity, particularly as it relates to making similar kinds of investments as those it proposes to make with the proceeds of QEIs; the applicant's prior performance in providing capital or technical assistance to disadvantaged businesses or communities; the projected level of the applicant's pipeline of potential investments; the extent to which the applicant intends to make Qualified Low-Income Community Investments (QLICIs) in one or more businesses in which persons unrelated to the entity hold a majority equity interest; and the extent to which applicants that otherwise have notable relationships with the QALICBs financed will create benefits (beyond those created in the normal course of a NMTC transaction) to Low-Income Communities.</P>
        <P>Under the Business Strategy criterion, an applicant will generally score well to the extent that it will deploy debt or investment capital in products or services which: (i) Are designed to meet the needs of underserved markets; (ii) are flexible or non-traditional in form and on better terms than available in the marketplace; and (iii) focus on customers or partners that typically lack access to conventional sources of capital. An applicant will also score well to the extent that, among other things, it: (i) Has a track record of successfully providing products and services similar to those it intends to use with the proceeds of QEIs; (ii) has identified, or has a process for identifying, potential transactions; (iii) demonstrates a likelihood of issuing QEIs and making the related QLICIs in a time period that is significantly shorter than the 5-year period permitted under IRC § 45D(b)(1); (iv) articulates a meaningful strategy for distributing any tax credit equity remaining at the end of the seven-year credit period and (v) in the case of an applicant proposing to purchase loans from CDEs, the applicant will require the CDE selling such loans to re-invest the proceeds of the loan sale to provide additional products and services to Low-Income Communities.</P>
        <P>(b)<E T="03">Priority Points:</E>In addition, as provided by IRC § 45D(f)(2), the CDFI Fund will ascribe additional points to entities that meet one or both of the statutory priorities. First, the CDFI Fund will give up to five (5) additional points to any applicant that has a record of having successfully provided capital or technical assistance to disadvantaged businesses or communities. Second, the CDFI Fund will give five (5) additional points to any applicant that intends to satisfy the requirement of IRC § 45D(b)(1)(B) by making QLICIs in one or more businesses in which persons unrelated (within the meaning of IRC § 267(b) or IRC § 707(b)(1)) to an applicant (or the applicant's subsidiary CDEs) hold the majority equity interest. Applicants may earn points for one or both statutory priorities. Thus, applicants that meet the requirements of both priority categories can receive up to a total of ten (10) additional points. A record of having successfully provided capital or technical assistance to disadvantaged businesses or communities may be demonstrated either by the past actions of an applicant itself or by its Controlling Entity (<E T="03">i.e.,</E>where a new CDE is established by a nonprofit corporation with a history of providing assistance to disadvantaged communities). An applicant that receives additional points for intending to make investments in unrelated businesses and is awarded a NMTC Allocation must meet the requirements of IRC § 45D(b)(1)(B) by investing substantially all of the proceeds from its QEIs in unrelated businesses. The CDFI Fund will factor in an applicant's priority points when ranking applicants during Phase 2 of the review process, as described below.</P>
        <P>2.<E T="03">Community Impact</E>(25-point maximum): In assessing the potential benefits to Low-Income Communities that may result from the applicant's proposed investments, reviewers will consider, among other things, the degree to which the applicant is likely to achieve significant and measurable community development outcomes in its Low-Income Communities, and whether the applicant is working in particularly economically distressed markets and/or in concert with Federal, state or local government or community economic development initiatives<E T="03">(i.e.,</E>Empowerment Zones, Enterprise Communities, and Renewal Communities). An applicant will generally score well under this section to the extent that: (a) It articulates how its strategy is likely to produce significant and measurable community development outcomes that would not be achieved without NMTCs; (b) it is working in particularly economically distressed or otherwise underserved communities and/or in concert with other Federal, State or local government or community economic development initiatives; and (c) it ensures that an investment into a project or business is<PRTPAGE P="32399"/>supported by and beneficial to the surrounding community.</P>
        <P>3.<E T="03">Management Capacity</E>(25-point maximum). In assessing an applicant's management capacity, reviewers will consider, among other things, the qualifications of the applicant's principals, its board members, its management team, and other essential staff or contractors, with specific focus on: experience in deploying capital or technical assistance, including activities similar to those described in the applicant's business strategy; asset management and risk management experience; experience with fulfilling compliance requirements of other governmental programs, including other tax programs; and the applicant's (or its Controlling Entity's) financial health. Reviewers will also consider the extent to which an applicant has protocols in place to ensure ongoing compliance with NMTC Program requirements and the level of involvement of community representatives in the Governing Board and/or Advisory Board in approving investment criteria or decisions.</P>
        <P>An applicant will generally score well under this section to the extent that its management team or other essential personnel have experience in: (a) Deploying capital or technical assistance in Low-Income Communities, particularly those likely to be served by the applicant with the proceeds of QEIs; (b) asset and risk management; and (c) fulfilling government compliance requirements, particularly tax credit program compliance. An applicant will also score well to the extent it demonstrates strong financial health and a high likelihood of remaining a going-concern; it has policies and systems in place to ensure ongoing compliance with NMTC Program requirements, and Low-Income Community representatives in the Governing Board and/or Advisory Board play an active role in designing or implementing its investment criteria and/or decisions.</P>
        <P>4.<E T="03">Capitalization Strategy</E>(25-point maximum): When assessing an applicant's capitalization strategy, reviewers will consider, among other things: the key personnel of the applicant's (or Controlling Entity's) and their track record of raising capital, particularly from for-profit investors; the extent to which the applicant has secured investments, commitments to invest in NMTC, or indications of investor interest commensurate with its requested amount of tax credit allocations; the applicant's strategy for identifying additional investors, if necessary, including the applicant's (or its Controlling Entity's) prior performance with raising equity from investors, particularly for-profit investors; the distribution of the economic benefits of the tax credit; the extent to which the applicant intends to invest the proceeds from the aggregate amount of its QEIs at a level that exceeds the requirements of IRC § 45D(b)(1)(B) and the IRS regulations; the likelihood the applicant will raise sufficient capital to finance its cost of operations while charging reasonable fees; and the applicant's timeline for utilizing an NMTC Allocation.</P>
        <P>An applicant will generally score well under this section to the extent that: (a) It has secured investor commitments, or has a reasonable strategy for obtaining such commitments; (b) its request for allocations is commensurate with both the level of QEIs it is likely to raise and its expected investment strategy to deploy funds raised with NMTCs; (c) it generally demonstrates that the economic benefits of the tax credit will be passed through to a QALICB; (d) it is likely to secure capital to finance its cost of operations and charge fees appropriate to the operational needs of the applicant; and (e) it intends to invest the proceeds from the aggregate amount of its QEIs at a level that exceeds the requirements of IRC § 45D(b)(1)(B) and the IRS regulations. In the case of an applicant proposing to raise investor funds from organizations that also will identify or originate transactions for the applicant or from affiliated entities, said applicant will score well to the extent that it will offer products with more favorable rates or terms than those currently offered by its investor(s) or Affiliated entities and/or will target its activities to areas of greater economic distress than those currently targeted by the investor or Affiliated entities.</P>
        <P>B.<E T="03">Review and selection process:</E>All allocation applications will be reviewed for eligibility and completeness. The CDFI Fund may consult with the IRS on the eligibility requirements under IRC § 45D. To be complete, the application must contain, at a minimum, all information described as required in the application form. An incomplete application will be rejected. Once the application has been determined to be eligible and complete, the CDFI Fund will conduct the substantive review of each application in two parts (Phase 1 and Phase 2) in accordance with the criteria and procedures generally described in this NOAA and the allocation application.</P>
        <P>1.<E T="03">Phase 1:</E>Reviewers will evaluate and score each application in the first part of the review process. An applicant must exceed a minimum overall aggregate base score threshold<E T="03">and</E>exceed a minimum aggregate section score threshold in each of the four application sections (Business Strategy, Community Impact, Management Capacity, and Capitalization Strategy) in order to advance from the first part of the substantive review process. If, in the case of a particular application, a reviewer's total base score or section score(s) (in one or more of the four application scored sections), varies significantly from other reviewers' total base scores or section scores for such application, the CDFI Fund may, in its sole discretion, obtain the comments and recommendations of an additional reviewer to determine whether the anomalous score should be replaced with the score of the additional reviewer.</P>
        <P>2.<E T="03">Phase 2:</E>Once the CDFI Fund has determined which applicants have met the required minimum overall aggregate base score and aggregate section score thresholds, the CDFI Fund will rank applicants on the basis of their combined scores in the Business Strategy and Community Impact sections of the application and will make adjustments to each applicant's priority points so that these points maintain the same relative weight in the ranking of applicant scores in Phase 2 as in Phase 1. The CDFI Fund will award allocations in the order of this “Final Rank Score,” subject to applicants' meeting all other eligibility requirements; provided, however, that the CDFI Fund, in its sole discretion, reserves the right to reject an application and/or adjust award amounts as appropriate based on information obtained during the review process. Most notably, in the cases of applicants (or their Affiliates) that are prior year allocatees, the CDFI Fund will review the activities of the prior year allocatee to determine whether the entity has: (a) effectively utilized its prior-year allocations; and (b) substantiated a need for additional allocation authority.</P>
        <P>3.<E T="03">Outstanding Reports:</E>In the case of an applicant, or Affiliates, that has previously received an award or allocation from the CDFI Fund through any CDFI Fund program, the CDFI Fund will deduct points for the applicant's (or its Affiliate's) failure to meet the reporting deadlines set forth in any assistance, award or Allocation Agreement(s) with the CDFI Fund during the entity's two complete fiscal years prior to the application deadline of this NOAA (generally FY 2009 and 2010).</P>
        <P>C.<E T="03">Allocations serving Non-Metropolitan counties:</E>As provided for under Section 102(b) of the Tax Relief<PRTPAGE P="32400"/>and Health Care Act of 2006 (Pub. L. 109-432), the CDFI Fund shall ensure that non-metropolitan counties receive a proportional allocation of Qualified Equity Investments (QEIs) under the NMTC Program. To this end, the CDFI Fund will ensure that the proportion of allocatees that are Rural CDEs is, at a minimum, equal to the proportion of applicants in the Phase 2 review pool that are Rural CDEs. The CDFI Fund will also endeavor to ensure that 20 percent of the QLICIs to be made using QEI proceeds are invested in Non-Metropolitan counties. A Rural CDE is one that has over the past five years dedicated at least 50 percent of its activities to Non-Metropolitan counties and has committed that at least 50 percent of its NMTC activities will be conducted in such areas. Non-Metropolitan counties are counties not contained within a Metropolitan Statistical Area, as such term is defined in OMB Bulletin No. 99-04 (Revised Statistical Definitions of Metropolitan Areas (MAs) and Guidance on Uses of MA Definitions) and applied using 2000 census data.</P>
        <P>Applicants that meet the minimum scoring thresholds will be advanced to Phase 2 review and will be provided with “preliminary” awards, in descending order of Final Rank Score, until the $3.5 billion in allocation authority is expended. Once these “preliminary” award amounts are determined, the CDFI Fund will then analyze the allocatee pool to determine whether the two Non-Metropolitan proportionality objectives have been met.</P>
        <P>The CDFI Fund will first examine the “preliminary” awards and allocatees to determine whether the percentage of allocatees that are Rural CDEs is, at a minimum, equal to the percentage of applicants in the Phase 2 review pool that are Rural CDEs. If this objective is not achieved, the CDFI Fund will provide awards to additional Rural CDEs from the Phase 2 pool, in descending order of their Final Rank Score, until the appropriate percentage balance is achieved. In order to accommodate the additional allocatees within the $3.5 billion allocation limitations, a formula reduction will be applied uniformly to the allocation amount for all allocatees in the pool.</P>
        <P>The CDFI Fund will then determine whether the pool of allocatees will, in the aggregate, invest at least 20 percent of their QLICIs (as measured by dollar amount) in Non-Metropolitan counties. The CDFI Fund will first apply the “minimum” percentage of QLICIs that allocatees indicated in their applications would be targeted to Non-Metropolitan areas to the total allocation award amount of each allocatee (less whatever percentage the allocatee indicated would be retained for non-QLICI activities), and total these figures for all allocatees. If this aggregate total is greater than or equal to 20 percent of the QLICIs to be made by the allocatees, then the pool is considered balanced and the CDFI Fund will proceed with the allocation process. However, if the aggregate total is less than 20 percent of the QLICIs to be made by the allocatees, the CDFI Fund will consider requiring any or all of the Allocatees to direct up to the “maximum” percentage of QLICIs that they indicated would be targeted to Non-Metropolitan counties; taking into consideration their track record and ability to deploy dollars in Non-Metropolitan counties. If the CDFI Fund cannot meet the goal of 20 percent of QLICIs in Non-Metropolitan counties, the CDFI Fund may add additional Rural CDEs (in descending order of final rank score) to the allocatee pool. In order to accommodate any additional allocatees within the $3.5 billion allocation limitations, a reduction would be applied, in as uniform a manner as possible, to the allocation amount for all allocatees in the pool that have not committed to investing at least 20 percent of their QLICIs in Non-Metropolitan counties.</P>
        <P>D.<E T="03">Questions:</E>All outstanding reports or compliance questions should be directed to the Certifications and Compliance Manager by e-mail at<E T="03">cme@cdfi.treas.gov;</E>by telephone at (202) 622-6330; by facsimile at (202) 622-7754; or by mail to CDFI Fund, 601 13th Street, NW., Suite 200 South, Washington, DC 20005. The CDFI Fund will respond to reporting or compliance questions between the hours of 9 a.m. and 5 p.m. ET, starting the date of the publication of this NOAA through July 25, 2011. The CDFI Fund will not respond to reporting or compliance phone calls or e-mail inquiries that are received after 5 p.m. ET on July 25, 2011 until after the funding application deadline of July 27, 2011.</P>
        <P>E.<E T="03">Right of rejection:</E>The CDFI Fund reserves the right to reject any NMTC allocation application in the case of a prior CDFI Fund awardee, if such applicant has failed to comply with the terms, conditions, and other requirements of the prior or existing assistance or award agreement(s) with the CDFI Fund. The CDFI Fund reserves the right to reject any NMTC allocation application in the case of a prior CDFI Fund Allocatee, if such applicant has failed to comply with the terms, conditions, and other requirements of its prior or existing Allocation Agreement(s) with the CDFI Fund. The CDFI Fund reserves the right to reject any NMTC allocation application in the case of any applicant, if an Affiliate of the applicant has failed to meet the terms, conditions and other requirements of any prior or existing assistance agreement, award agreement or Allocation Agreement with the CDFI Fund.</P>
        <P>The CDFI Fund reserves the right to reject any NMTC allocation application in the case of a prior CDFI Fund Allocatee, if such applicant has failed to use its prior NMTC allocation(s) in a manner that is generally consistent with the business strategy (including, but not limited to, the proposed product offerings and markets served) set forth in the allocation application(s) related to such prior allocation(s). The CDFI Fund also reserves the right to reject any NMTC allocation application in the case of an Affiliate of the applicant that is a prior CDFI Fund Allocatee and has failed to use its prior NMTC allocation(s) in a manner that is generally consistent with the business strategy set forth in the allocation application(s) related to such prior allocation(s).</P>
        <P>The CDFI Fund reserves the right to reject a NMTC allocation application if information (including administrative errors) comes to the attention of the CDFI Fund that adversely affects an applicant's eligibility for an award, adversely affects the CDFI Fund's evaluation or scoring of an application, adversely affects the CDFI Fund's prior determinations of CDE certification, or indicates fraud or mismanagement on the part of an applicant or the Controlling Entity, if such fraud or mismanagement by the Controlling Entity would hinder the applicant's ability to perform under the allocation agreement. If the CDFI Fund determines that any portion of the application is incorrect in any material respect, the CDFI Fund reserves the right, in its sole discretion, to reject the application.</P>

        <P>As a part of the substantive review process, the CDFI Fund may permit the Allocation Recommendation Panel member(s) to make telephone calls to applicants for the sole purpose of obtaining, clarifying or confirming application information. In no event shall such contact be construed to permit an applicant to change any element of its application. Reviewers will not contact applicants without the prior approval of the CDFI Fund. At this point in the process, an applicant may be required to submit additional information about its application in order to assist the CDFI Fund with its final evaluation process. Such requests<PRTPAGE P="32401"/>must be responded to within the time parameters set by the CDFI Fund. The selecting official(s) will make a final allocation determination based on an applicant's file, including, without limitation, eligibility under IRC § 45D, the reviewers' scores and the amount of allocation authority available. In the case of applicants (or Affiliates of applicants) that are regulated by the Federal government or a State agency (or comparable entity), the CDFI Fund's selecting official(s) reserve(s) the right to consult with and take into consideration the views of the appropriate Federal or State banking and other regulatory agencies. In the case of applicants (or Affiliates of applicants) that are also Small Business Investment Companies, Specialized Small Business Investment Companies or New Markets Venture Capital Companies, the CDFI Fund reserves the right to consult with and take into consideration the views of the Small Business Administration.</P>
        <P>The CDFI Fund reserves the right to conduct additional due diligence, as determined reasonable and appropriate by the CDFI Fund, in its sole discretion, related to the applicant, the applicant's Controlling Entity and the officers, directors, owners, partners and key employees of each.</P>
        <P>Each applicant will be informed of the CDFI Fund's award decision through an electronic notification whether selected for an allocation (see Section VI.A. of this NOAA) or not selected for an allocation, which may be for reasons of application incompleteness, ineligibility or substantive issues. All applicants that are not selected for an allocation based on substantive issues will likely be given the opportunity to obtain feedback on their applications. This feedback will be provided in a format and within a timeframe to be determined by the CDFI Fund, based on available resources.</P>
        <P>The CDFI Fund further reserves the right to change its eligibility and evaluation criteria and procedures, if the CDFI Fund deems it appropriate. If said changes materially affect the CDFI Fund's award decisions, the CDFI Fund will provide information regarding the changes through the CDFI Fund's website.</P>
        <P>There is no right to appeal the CDFI Fund's allocation decisions. The CDFI Fund's allocation decisions are final.</P>
        <HD SOURCE="HD1">VI. Award Administration Information</HD>
        <P>1.<E T="03">Failure to meet reporting requirements:</E>If an Allocatee, or an Affiliate of an Allocatee, is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program and is not current on the reporting requirements set forth in the previously executed assistance, allocation or award agreement(s), as of the date of the award notification or thereafter, the CDFI Fund reserves the right, in its sole discretion, to delay entering into an Allocation Agreement and/or to impose limitations on an Allocatee's ability to issue QEIs to investors until said prior awardee or Allocatee is current on the reporting requirements in the previously executed assistance, allocation or award agreement(s). Please note that the CDFI Fund only acknowledges the receipt of reports that are complete. As such, incomplete reports or reports that are deficient of required elements will not be recognized as having been received. If said prior awardee or Allocatee is unable to meet this requirement within the timeframe set by the CDFI Fund, the CDFI Fund reserves the right, in its sole discretion, to terminate and rescind the allocation made under this NOAA.</P>
        <P>2.<E T="03">Pending resolution of noncompliance:</E>If an Allocatee is a prior awardee or Allocatee under any CDFI Fund program and if: (i) It has submitted complete and timely reports to the CDFI Fund that demonstrate noncompliance with a previous assistance, award or Allocation Agreement; and (ii) the CDFI Fund has yet to make a final determination as to whether the entity is in default of its previous assistance, award or Allocation Agreement, the CDFI Fund reserves the right, in its sole discretion, to delay entering into an Allocation Agreement and/or to impose limitations on the Allocatee's ability to issue Qualified Equity Investments to investors, pending full resolution, in the sole determination of the CDFI Fund, of the noncompliance. Further, if an Affiliate of an Allocatee is a prior CDFI Fund awardee or Allocatee and if such entity: (i) Has submitted complete and timely reports to the CDFI Fund that demonstrate noncompliance with a previous assistance, award or Allocation Agreement; and (ii) the CDFI Fund has yet to make a final determination as to whether the entity is in default of its previous assistance, award or Allocation Agreement, the CDFI Fund reserves the right, in its sole discretion, to delay entering into an Allocation Agreement and/or to impose limitations on the Allocatee's ability to issue QEIs to investors, pending full resolution, in the sole determination of the CDFI Fund, of the noncompliance. If the prior awardee or Allocatee in question is unable to satisfactorily resolve the issues of noncompliance, in the sole determination of the CDFI Fund, the CDFI Fund reserves the right, in its sole discretion, to terminate and rescind the award notification made under this NOAA.</P>
        <P>3.<E T="03">Default status:</E>If, at any time prior to entering into an Allocation Agreement through this NOAA, the CDFI Fund has made a final determination that an Allocatee that is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program is in default of a previously executed assistance, allocation or award agreement(s) and has provided written notification of such determination to the Allocatee, the CDFI Fund reserves the right, in its sole discretion, to delay entering into an Allocation Agreement and/or to impose limitations on the Allocatee's ability to issue QEIs to investors, until said prior awardee or Allocatee has submitted a complete and timely report demonstrating full compliance with said agreement within a timeframe set by the CDFI Fund. Further, if at any time prior to entering into an Allocation Agreement through this NOAA, the CDFI Fund has made a final determination that an Affiliate of the Allocatee is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program, and is in default of a previously executed assistance, allocation or award agreement(s) and has provided written notification of such determination to the defaulting entity, the CDFI Fund reserves the right, in its sole discretion, to delay entering into an Allocation Agreement and/or to impose limitations on the Allocatee's ability to issue QEIs to investors, until said prior awardee or Allocatee has submitted a complete and timely report demonstrating full compliance with said agreement within a timeframe set by the CDFI Fund. If said prior awardee or Allocatee is unable to meet this requirement, the CDFI Fund reserves the right, in its sole discretion, to terminate and rescind the Notice of Allocation and the allocation made under this NOAA.</P>
        <P>4.<E T="03">Termination in default:</E>If (i) within the 12-month period prior to entering into an Allocation Agreement through this NOAA, the CDFI Fund has made a final determination that an Allocatee that is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program whose award or allocation was terminated in default of such prior agreement; (ii) the CDFI Fund has provided written notification of such determination to such organization; and (iii) the final reporting period end date for the applicable terminated agreement falls in such organization's 2009 or 2010 fiscal year, the CDFI Fund reserves the right, in its sole discretion, to delay entering into an Allocation Agreement and/or to impose limitations on the Allocatee's ability to issue QEIs to<PRTPAGE P="32402"/>investors. Furthermore, if (i) within the 12-month period prior to entering into an Allocation Agreement through this NOAA, the CDFI Fund has made a final determination that an Affiliate of the Allocatee is a prior CDFI Fund awardee or Allocatee under any CDFI Fund program whose award or allocation was terminated in default of such prior agreement; (ii) the CDFI Fund has provided written notification of such determination to the defaulting entity; and (iii) the final reporting period end date for the applicable terminated agreement falls in such defaulting entity's 2009 or 2010 fiscal year, the CDFI Fund reserves the right, in its sole discretion, to delay entering into an Allocation Agreement and/or to impose limitations on the Allocatee's ability to issue QEIs to investors.</P>
        <P>5.<E T="03">Allocation Agreement:</E>Each applicant that is selected to receive a NMTC Allocation (including the applicant's Subsidiary transferees) must enter into an Allocation Agreement with the CDFI Fund. The Allocation Agreement will set forth certain required terms and conditions of the NMTC Allocation which may include, but are not limited to, the following: (i) The amount of the awarded NMTC Allocation; (ii) the approved uses of the awarded NMTC Allocation (<E T="03">i.e.,</E>loans to or equity investments in Qualified Active Low-Income Businesses or loans to or equity investments in other CDEs); (iii) the approved service area(s) in which the proceeds of QEIs may be used, including the dollar amount of QLICIs that must be invested in Non-Metropolitan counties; (iv) the time period by which the applicant may obtain QEIs from investors; (v) reporting requirements for all applicants receiving NMTC Allocations; and (vi) a requirement to maintain certification as a CDE throughout the term of the Allocation Agreement. If an applicant has represented in its NMTC allocation application that it intends to invest substantially all of the proceeds from its investors in businesses in which persons unrelated to the applicant hold a majority equity interest, the Allocation Agreement will contain a covenant whereby said applicant agrees that it will invest substantially all of said proceeds in businesses in which persons unrelated to the applicant hold a majority equity interest.</P>
        <P>In addition to entering into an Allocation Agreement, each applicant selected to receive a NMTC Allocation must furnish to the CDFI Fund an opinion from its legal counsel or a similar certification, the content of which will be further specified in the Allocation Agreement, to include, among other matters, an opinion that an applicant (and its Subsidiary transferees, if any): (i) Is duly formed and in good standing in the jurisdiction in which it was formed and the jurisdiction(s) in which it operates; (ii) has the authority to enter into the Allocation Agreement and undertake the activities that are specified therein; (iii) has no pending or threatened litigation that would materially affect its ability to enter into and carry out the activities specified in the Allocation Agreement; and (iv) is not in default of its articles of incorporation, bylaws or other organizational documents, or any agreements with the Federal government.</P>
        <P>If an Allocatee identifies Subsidiary transferees, the CDFI Fund reserves the right to require an Allocatee to provide supporting documentation evidencing that it Controls such entities prior to entering into an Allocation Agreement with the Allocatee and its Subsidiary transferees. The CDFI Fund reserves the right, in its sole discretion, to rescind its allocation award if the Allocatee fails to return the Allocation Agreement, signed by the authorized representative of the Allocatee, and/or provide the CDFI Fund with any other requested documentation, within the deadlines set by the CDFI Fund.</P>
        <P>6.<E T="03">Fees:</E>The CDFI Fund reserves the right, in accordance with applicable Federal law and if authorized, to charge allocation reservation and/or compliance monitoring fees to all entities receiving NMTC Allocations. Prior to imposing any such fee, the CDFI Fund will publish additional information concerning the nature and amount of the fee.</P>
        <P>7.<E T="03">Reporting:</E>The CDFI Fund will collect information, on at least an annual basis from all applicants that are awarded NMTC Allocations and/or are recipients of QLICIs, including such audited financial statements and opinions of counsel as the CDFI Fund deems necessary or desirable, in its sole discretion. The CDFI Fund will use such information to monitor each Allocatee's compliance with the provisions of its Allocation Agreement and to assess the impact of the NMTC Program in Low-Income Communities. The CDFI Fund may also provide such information to the IRS in a manner consistent with IRC § 6103 so that the IRS may determine, among other things, whether the Allocatee has used substantially all of the proceeds of each QEI raised through its NMTC Allocation to make QLICIs. The Allocation Agreement shall further describe the Allocatee's reporting requirements.</P>
        <P>The CDFI Fund reserves the right, in its sole discretion, to modify these reporting requirements if it determines it to be appropriate and necessary; however, such reporting requirements will be modified only after due notice to Allocatees.</P>
        <HD SOURCE="HD1">VII. Agency Contacts</HD>

        <P>The CDFI Fund will provide programmatic and information technology support related to the allocation application between the hours of 9 a.m. and 5:00 p.m. ET through July 25, 2011. The CDFI Fund will not respond to phone calls or e-mails concerning the application that are received after 5 p.m. ET on July 25, 2011 until after the allocation application deadline of July 27, 2011. Applications and other information regarding the CDFI Fund and its programs may be obtained from the CDFI Fund's Web site at<E T="03">http://www.cdfifund.gov.</E>The CDFI Fund will post on its Web site responses to questions of general applicability regarding the NMTC Program.</P>
        <P>A.<E T="03">Information technology support:</E>Technical support can be obtained by calling (202) 622-2455 or by e-mail at<E T="03">ithelpdesk@cdfi.treas.gov.</E>People who have visual or mobility impairments that prevent them from accessing the Low-Income Community maps using the CDFI Fund's Web site should call (202) 622-2455 for assistance. These are not toll free numbers.</P>
        <P>B.<E T="03">Programmatic support:</E>If you have any questions about the programmatic requirements of this NOAA, contact the CDFI Fund's NMTC Program Manager by e-mail at<E T="03">cdfihelp@cdfi.treas.gov,</E>by telephone at (202) 622-6355, by facsimile at (202) 622-7754, or by mail at CDFI Fund, 601 13th Street, NW., Suite 200 South, Washington, DC 20005. These are not toll-free numbers.</P>
        <P>C.<E T="03">Administrative support:</E>If you have any questions regarding the administrative requirements of this NOAA, contact the CDFI Fund's NMTC Program Manager by e-mail at<E T="03">cdfihelp@cdfi.treas.gov,</E>by telephone at (202) 622-6355, by facsimile at (202) 622-7754, or by mail at CDFI Fund, 601 13th Street, NW., Suite 200 South, Washington, DC 20005. These are not toll free numbers.</P>
        <P>D.<E T="03">IRS support:</E>For questions regarding the tax aspects of the NMTC Program, contact Branch Five, Office of the Associate Chief Counsel (Passthroughs and Special Industries), IRS, by telephone at (202) 622-3040, by facsimile at (202) 622-4753, or by mail at 1111 Constitution Avenue, NW., Attn: CC:PSI:5, Washington, DC 20224. These are not toll free numbers.<PRTPAGE P="32403"/>
        </P>
        <P>E.<E T="03">Legal counsel support:</E>If you have any questions or matters that you believe require response by the CDFI Fund's Office of Legal Counsel, please refer to the document titled “How to Request a Legal Review,” found on the CDFI Fund's Web site at<E T="03">http://www.cdfifund.gov.</E>
        </P>
        <HD SOURCE="HD1">VIII. Information Sessions</HD>

        <P>In connection with this NOAA, the CDFI Fund may conduct multiple information sessions around the country at locations to be announced, as well as an information session that will be produced in Washington, DC and broadcast over the Internet via webcasting. For further information on these upcoming information sessions, please visit the CDFI Fund's Web site at<E T="03">http://www.cdfifund.gov</E>or call the CDFI Fund at (202) 927-6224.</P>
        <AUTH>
          <HD SOURCE="HED">Authority:</HD>
          <P>26 U.S.C. 45D; 31 U.S.C. 321; 26 CFR 1.45D-1.</P>
        </AUTH>
        <SIG>
          <DATED>Dated: May 27, 2011.</DATED>
          <NAME>Donna J. Gambrell,</NAME>
          <TITLE>Director, Community Development Financial Institutions Fund.</TITLE>
        </SIG>
      </PREAMB>
      <FRDOC>[FR Doc. 2011-13864 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4810-70-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Proposed Collection; Comment Request for Form 2678</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 2678, Employer/Payer Appointment of Agent.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to Yvette Lawrence, Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala at Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 622-3634, or through the Internet at<E T="03">RJoseph.Durbala@irs.gov</E>.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>
        <P>
          <E T="03">Title:</E>Employer/Payer Appointment of Agent.</P>
        <P>
          <E T="03">OMB Number:</E>1545-0748.</P>
        <P>
          <E T="03">Form Number:</E>2678.</P>
        <P>
          <E T="03">Abstract:</E>Internal Revenue Code section 3504 authorizes a fiduciary, agent or other person to perform acts of an employer for purposes of employment taxes. Form 2678 is used to empower an agent with the responsibility and liability of collecting and paying the employment taxes including backup withholding and filing the appropriate tax return.</P>
        <P>
          <E T="03">Current Actions:</E>There are no changes being made to the burden previously approved by OMB at this time.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of a currently approved collection.</P>
        <P>
          <E T="03">Affected Public:</E>Businesses or other for-profit organizations, not-for-profit institutions, farms and the Federal Government.</P>
        <P>
          <E T="03">Estimated Number of Respondents:</E>6,130,000.</P>
        <P>
          <E T="03">Estimated Time per Respondent:</E>2.24 hours.</P>
        <P>
          <E T="03">Estimated Total Annual Burden Hours:</E>13,731,000.</P>
        <P>The following paragraph applies to all of the collections of information covered by this notice:</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.</P>
        <P>
          <E T="03">Request for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 25, 2011.</DATED>
          <NAME>Yvette Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13859 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Agency Information Collection Activities: Submissions and Approvals</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). The IRS is soliciting comments concerning information collection requirements related to Domestic Reinvestment Plans and Other Guidance under Section 965.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to Yvette B. Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Requests for additional information or copies of the regulations should be directed to Joel Goldberger at Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 927-9368, or through the Internet at<E T="03">Joel.P.Goldberger@irs.gov).</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P SOURCE="NPAR">
          <E T="03">Title:</E>Domestic Reinvestment and Other Guidance under Section 965.</P>
        <P>
          <E T="03">OMB Number:</E>1545-1926.</P>
        <P>
          <E T="03">Regulation Project Number:</E>Notice 2005-10, as modified by Notice 2005-38.</P>
        <P>
          <E T="03">Abstract:</E>Notice 2005-10 provides guidance concerning new section 965 of the Internal Revenue Code (Code). It sets forth general principles and specific<PRTPAGE P="32404"/>guidance on domestic reinvestment plans and on investments in the United States described in section 965(b)(4)(B). The Treasury Department and the Internal Revenue Service (IRS) intend to issue additional notices providing guidance concerning section 965, including rules relating to the foreign tax credit and expense allocation, rules for adjusting the calculation of the base period amounts to take into account mergers, acquisitions and spin-offs, and rules regarding controlled groups. The Treasury Department and the IRS expect to issue regulations that incorporate the guidance provided in this and the subsequent notices. Notice 2005-38 primarily addresses the limitations, described in section 965(b)(1), (2), and (3), on the amount of dividends that a corporation that is a U.S. shareholder of a controlled foreign corporation may treat as eligible for the dividends received deduction under section 965(a) (DRD or section 965(a) DRD), including the effects of certain transactions on such limitations.</P>
        <P>
          <E T="03">Current Actions:</E>There is no change to this existing regulation.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of currently approved collection.</P>
        <P>
          <E T="03">Affected Public:</E>Business or other for-profit organizations.</P>
        <P>
          <E T="03">Estimated Number of Respondents:</E>25,000.</P>
        <P>
          <E T="03">Estimated Time per Respondent:</E>150 hours.</P>
        <P>
          <E T="03">Estimated Total Annual Burden Hours:</E>3,750,000.</P>
        <P>The following paragraph applies to all of the collections of information covered by this notice:</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.</P>
        <P>
          <E T="03">Request for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 18, 2011.</DATED>
          <NAME>Yvette B. Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13891 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Proposed Collection; Comment Request for Form 8864</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8864, Biodiesel Fuels Credit.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to, Yvette B. Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Requests for additional information or copies of the form(s) and instructions should be directed to Joel Goldberger (202) 927-9368, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet at<E T="03">Joel.P.Goldberger@irs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P SOURCE="NPAR">
          <E T="03">Title:</E>Biodiesel Fuels Credit.</P>
        <P>
          <E T="03">OMB Number:</E>1545-1924.</P>
        <P>
          <E T="03">Form Number:</E>8864.</P>
        <P>
          <E T="03">Abstract:</E>The American Jobs Creation Act of 2004, section 302, added new code section 40A, credit for biodiesel used as a fuel. Form 8864 has been developed to allow taxpayers to compute the biodiesel fuels credit. Section 38(b)(17) allows the biodiesel credit to be taken as a credit against income tax for businesses that sell or use biodiesel mixed with other fuels or sold as straight biodiesel.</P>
        <P>
          <E T="03">Current Actions:</E>There are no changes being made to Form 8864 at this time.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of a currently approved collection.</P>
        <P>
          <E T="03">Affected Public:</E>Business or other for-profit.</P>
        <P>
          <E T="03">Estimated Number of Respondents:</E>40.</P>
        <P>
          <E T="03">Estimated Total Annual Burden Hours:</E>310.</P>
        <P>The following paragraph applies to all of the collections of information covered by this notice:</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.</P>
        <P>
          <E T="03">Request for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 20, 2011.</DATED>
          <NAME>Yvette B. Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13890 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <PRTPAGE P="32405"/>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Proposed Collection; Comment Request for Revenue Procedure 2003-84</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Revenue Procedure 2003-84, Optional election to make monthly 706(a) computations.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to Yvette Lawrence, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Requests for additional information or copies of the regulations should be directed to R. Joseph Durbala at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 622-3634, or through the Internet at<E T="03">RJoseph.Durbala@irs.gov</E>.</P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>
        <P>
          <E T="03">Title:</E>Optional election to make monthly 706(a) computations.</P>
        <P>
          <E T="03">OMB Number:</E>1545-1768.</P>
        <P>
          <E T="03">Revenue Procedure Number:</E>Revenue Procedure 2003-84.</P>
        <P>
          <E T="03">Abstract:</E>This procedure allows certain partnerships that invest in tax-exempt obligations to make an election that enables the partners to take into account monthly the inclusions required under sections 702 and 707(c) of the Code and provides rules for partnership income tax reporting under section 6031 for such partnerships. Rev. Proc. 2002-68 modified and superseded.</P>
        <P>
          <E T="03">Current Actions:</E>There are no changes being made to the revenue procedure at this time.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of a currently approved collection.</P>
        <P>
          <E T="03">Affected Public:</E>Business or other for-profit organizations.</P>
        <P>
          <E T="03">Estimated Number of Respondents/Recordkeepers:</E>1,000.</P>
        <P>
          <E T="03">Estimated Time per Respondent/Recordkeeper:</E>
          <FR>1/2</FR>hour.</P>
        <P>
          <E T="03">Estimated Total Annual Reporting/Recordkeeping Hours.</E>500.</P>
        <P>The following paragraph applies to all the collections of information covered by this notice:</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.</P>
        <P>
          <E T="03">Request for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 24, 2011.</DATED>
          <NAME>Yvette Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13863 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Proposed Collection; Comment Request for Form 12114</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 12114, Continuation Sheet for Item #15 (Additional Information) OF-306, Declaration for Federal Employment.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to Yvette Lawrence Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala, at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 622-3634, or through the Internet at<E T="03">RJoseph.Durbala@irs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P SOURCE="NPAR">
          <E T="03">Title:</E>Continuation Sheet for Item #15 (Additional Information) OF-306, Declaration for Federal Employment.</P>
        <P>
          <E T="03">OMB Number:</E>1545-1921.</P>
        <P>
          <E T="03">Form Number:</E>12114.</P>
        <P>
          <E T="03">Abstract:</E>This form is used by recruitment personnel of the Covington Host Site. This form is provided to applicants when completing OF 306, Declaration for Federal Employment. It is used as a continuation sheet to clearly define additional information that is requested in item 15 of the OF 306. Due to lack of space on the OF 306 this form can be used in lieu of an additional sheet of paper.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of a currently approved collection.</P>
        <P>
          <E T="03">Affected Public:</E>Individuals or households.</P>
        <P>
          <E T="03">Estimated Number of Respondents:</E>24,813.</P>
        <P>
          <E T="03">Estimated Time per Respondent:</E>15 minutes.</P>
        <P>
          <E T="03">Estimated Total Annual Burden Hours:</E>6,203.</P>
        <P>The following paragraph applies to all of the collections of information covered by this notice:</P>

        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.<PRTPAGE P="32406"/>
        </P>
        <P>
          <E T="03">Request for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 24, 2011.</DATED>
          <NAME>Yvette Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13865 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Proposed Collection; Comment Request for Form 8878-A</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8878-A, IRS e-file Electronic Funds Withdrawal Authorization for Form 7004.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to Yvette Lawrence, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Requests for additional information or copies of the form and instructions should be directed to Allan Hopkins, at (202) 622-6665, or at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet, at<E T="03">Allan.M.Hopkins@irs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P SOURCE="NPAR">
          <E T="03">Title:</E>IRS e-file Electronic funds Withdrawal Authorization for Form 7004.</P>
        <P>
          <E T="03">OMB Number:</E>1545-1927.</P>
        <P>
          <E T="03">Form Number:</E>8878-A.</P>
        <P>
          <E T="03">Abstract:</E>Form 8878-A is used by a corporate officer or agent and an electronic return originator (ERO) to use a personal identification number (PIN) to authorize an electronic funds withdrawal for a tax payment made with a request to extend the filing due date for a corporate income tax return.</P>
        <P>
          <E T="03">Current Actions:</E>There are no changes being made to the form at this time.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of a currently approved collection.</P>
        <P>
          <E T="03">Affected Public:</E>Business or other for-profit organizations.</P>
        <P>
          <E T="03">Estimated Number of Respondents:</E>140,000.</P>
        <P>
          <E T="03">Estimated Time per Respondent:</E>3 hours, 37 minutes.</P>
        <P>
          <E T="03">Estimated Total Annual Burden Hours:</E>505,400.</P>
        <P>The following paragraph applies to all of the collections of information covered by this notice:</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.</P>
        <P>Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.</P>
        <P>
          <E T="03">Request for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 18, 2011.</DATED>
          <NAME>Yvette Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13866 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Proposed Collection; Comment Request for Form 4684</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 4684, Casualties and Thefts.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to Yvette Lawrence, Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala, (202) 622-3634, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224 or through the Internet at<E T="03">RJoseph.Durbala@irs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P SOURCE="NPAR">
          <E T="03">Title:</E>Casualties and Thefts.</P>
        <P>
          <E T="03">OMB Number:</E>1545-0177.</P>
        <P>
          <E T="03">Form Number:</E>4684.</P>
        <P>
          <E T="03">Abstract:</E>Form 4684 is used by taxpayers to compute their gain or loss from casualties or thefts, and to summarize such gains and losses. The data is used to verify that the correct gain or loss has been computed.</P>
        <P>
          <E T="03">Current Actions:</E>There are no changes being made to the form at this time.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of a currently approved collection.</P>
        <P>
          <E T="03">Affected Public:</E>Individuals or households and business or other for-profit organizations.<PRTPAGE P="32407"/>
        </P>
        <P>
          <E T="03">Estimated Number of Respo</E>ndents: 268,350.</P>
        <P>
          <E T="03">Estimated Time per Respondent:</E>5 hrs., 32 min.</P>
        <P>
          <E T="03">Estimated Total Annual Burden Hours:</E>1,486,659.</P>
        <P>The following paragraph applies to all of the collections of information covered by this notice:</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.</P>
        <P>Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection</P>
        <P>of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 25, 2011.</DATED>
          <NAME>Yvette Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13867 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Proposed Collection; Comment Request for Form 12311</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 12311, Notice Regarding Repayment of a Buyout Prior to Re-employment with the Federal Government.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to, Yvette B. Lawrence, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>

          <P>Requests for additional information or copies of the form(s) and instructions should be directed to Joel Goldberger, (202) 927-9368, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet at<E T="03">Joel.P.Goldberger@irs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P/>
        <P>
          <E T="03">Title:</E>Notice Regarding Repayment of a Buyout Prior to Re-employment with the Federal Government.</P>
        <P>
          <E T="03">OMB Number:</E>1545-1920.</P>
        <P>
          <E T="03">Form Number:</E>Form 12311.</P>
        <P>
          <E T="03">Abstract:</E>This form requests applicants to certify if they ever worked for the Federal Government and if they received a Buyout within the last 5 years. This is to ensure that applicants who meet the criteria are counseled that they are required to pay back the entire Buyout prior to entering on duty with the IRS.</P>
        <P>
          <E T="03">Current Actions:</E>There are no changes being made to these forms at this time.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of a currently approved collection.</P>
        <P>
          <E T="03">Affected Public:</E>Individuals or households and Federal Government.</P>
        <P>
          <E T="03">Estimated Number of Responses:</E>33,085.</P>
        <P>
          <E T="03">Estimated Time Per Response:</E>5 minutes.</P>
        <P>
          <E T="03">Estimated Total Annual Burden Hours:</E>2,757.</P>
        <P>The following paragraph applies to all of the collections of information covered by this notice:</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.</P>
        <P>
          <E T="03">Request for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 17, 2011.</DATED>
          <NAME>Yvette B. Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13868 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
    <NOTICE>
      <PREAMB>
        <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
        <SUBAGY>Internal Revenue Service</SUBAGY>
        <SUBJECT>Proposed Collection; Comment Request for Regulation Project</SUBJECT>
        <AGY>
          <HD SOURCE="HED">AGENCY:</HD>
          <P>Internal Revenue Service (IRS), Treasury.</P>
        </AGY>
        <ACT>
          <HD SOURCE="HED">ACTION:</HD>
          <P>Notice and request for comments.</P>
        </ACT>
        <SUM>
          <HD SOURCE="HED">SUMMARY:</HD>
          <P>The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). The IRS is soliciting comments concerning information collection requirements related to Purchase Price Allocations in Deemed and Actual Asset Acquisitions.</P>
        </SUM>
        <DATES>
          <HD SOURCE="HED">DATES:</HD>
          <P>Written comments should be received on or before August 5, 2011 to be assured of consideration.</P>
        </DATES>
        <ADD>
          <HD SOURCE="HED">ADDRESSES:</HD>
          <P>Direct all written comments to Yvette B. Lawrence, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.</P>
        </ADD>
        <FURINF>
          <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
          <P>Requests for additional information or<PRTPAGE P="32408"/>copies of the regulations should be directed to Joel Goldberger, at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 927-9368, or through the Internet at<E T="03">Joel.P.Goldberger@irs.gov.</E>
          </P>
        </FURINF>
      </PREAMB>
      <SUPLINF>
        <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
        <P SOURCE="NPAR">
          <E T="03">Title:</E>Purchase Price Allocation in Deemed and Actual Asset Acquisition.</P>
        <P>
          <E T="03">OMB Number:</E>1545-1658.</P>
        <P>
          <E T="03">Regulation Project Number:</E>REG-107069-97 (T.D. 8940).</P>
        <P>
          <E T="03">Abstract:</E>Section 338 of the Internal Revenue Code provides rules under which a qualifying stock acquisition is treated as an asset acquisition (a “deemed asset acquisition”) when an appropriate election is made. Section 1060 provides rules for the allocation of consideration when a trade or business is transferred. The collection of information is necessary to make the election, to calculate and collect the appropriate amount of tax liability when a qualifying stock acquisition is made, to determine the persons liable for such tax, and to determine the bases of assets acquired in the deemed asset acquisition.</P>
        <P>
          <E T="03">Current Actions:</E>There are no changes to the paperwork burden previously approved by OMB. This document is being submitted for renewal purposes only.</P>
        <P>
          <E T="03">Type of Review:</E>Extension of OMB approval.</P>
        <P>
          <E T="03">Affected Public:</E>Business or other for-profit organizations, and farms.</P>
        <P>The regulation provides that a section 338 election is made by filing Form 8023. The burden for this requirement is reflected in the burden of Form 8023. The regulation also provides that both a seller and a purchaser must each file an asset acquisition statement on Form 8594. The burden for this requirement is reflected in the burden of Form 8594.</P>
        <P>The burden for the collection of information in § 1.338-2T(e)(4) is as follows:</P>
        <P>
          <E T="03">Estimated Number of Respondents/Recordkeeper:</E>45.</P>
        <P>
          <E T="03">Estimated Average Annual Burden per Respondent/Recordkeeper:</E>34 minutes.</P>
        <P>
          <E T="03">Estimated Total Annual Reporting/Recordkeeping Hours:</E>25.</P>
        <P>The following paragraph applies to all of the collections of information covered by this notice:</P>
        <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.</P>
        <P>
          <E T="03">Request for Comments:</E>Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
        <SIG>
          <DATED>Approved: May 18, 2011.</DATED>
          <NAME>Yvette B. Lawrence,</NAME>
          <TITLE>IRS Reports Clearance Officer.</TITLE>
        </SIG>
      </SUPLINF>
      <FRDOC>[FR Doc. 2011-13869 Filed 6-3-11; 8:45 am]</FRDOC>
      <BILCOD>BILLING CODE 4830-01-P</BILCOD>
    </NOTICE>
  </NOTICES>
  <VOL>76</VOL>
  <NO>108</NO>
  <DATE>Monday, June 6, 2011</DATE>
  <UNITNAME>Proposed Rules</UNITNAME>
  <NEWPART>
    <PTITLE>
      <PRTPAGE P="32409"/>
      <PARTNO>Part II</PARTNO>
      <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
      <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
      <HRULE/>
      <CFR>42 CFR Part 414</CFR>
      <TITLE>Medicare Program; Five-Year Review of Work Relative Value Units Under the Physician Fee Schedule; Proposed Rule</TITLE>
    </PTITLE>
    <PRORULES>
      <PRORULE>
        <PREAMB>
          <PRTPAGE P="32410"/>
          <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
          <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
          <CFR>42 CFR Part 414</CFR>
          <DEPDOC>[CMS-1582-PN]</DEPDOC>
          <RIN>RIN 0938-AQ87</RIN>
          <SUBJECT>Medicare Program; Five-Year Review of Work Relative Value Units Under the Physician Fee Schedule</SUBJECT>
          <AGY>
            <HD SOURCE="HED">AGENCY:</HD>
            <P>Centers for Medicare &amp; Medicaid Services (CMS), HHS.</P>
          </AGY>
          <ACT>
            <HD SOURCE="HED">ACTION:</HD>
            <P>Proposed notice.</P>
          </ACT>
          <SUM>
            <HD SOURCE="HED">SUMMARY:</HD>
            <P>This proposed notice sets forth proposed revisions to work relative value units (RVUs) and corresponding changes to the practice expense and malpractice RVUs affecting payment for physicians' services. The statute requires that we review RVUs no less often than every 5 years. This is our Fourth Five-Year Review of Work RVUs since we implemented the physician fee schedule (PFS) on January 1, 1992. These revisions to work RVUs are proposed to be effective for services furnished beginning January 1, 2012. These revisions reflect changes in medical practice and coding that affect the relative amount of physician work required to perform each service as required by the statute. The Fourth Five-Year Review of Work includes services that were submitted through public comment and by the Medicare contractor medical directors (CMDs), as well as a number of potentially misvalued codes identified by CMS (that is, Harvard valued codes and codes with Site-of-Service anomalies).</P>
          </SUM>
          <DATES>
            <HD SOURCE="HED">DATES:</HD>
            <P>To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on July 25, 2011.</P>
          </DATES>
          <ADD>
            <HD SOURCE="HED">ADDRESSES:</HD>
            <P>In commenting, please refer to file code CMS-1582-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.</P>
            <P>You may submit comments in one of four ways (please choose only one of the ways listed).</P>
            <P>1.<E T="03">Electronically.</E>You may submit electronic comments on this regulation to<E T="03">http://www.regulations.gov.</E>Follow the “Submit a comment” instructions.</P>
            <P>2.<E T="03">By regular mail.</E>You may mail written comments to the following address only:Centers for Medicare &amp; Medicaid Services,Department of Health and Human Services,Attention: CMS-1582-PN,P.O. Box 8013,Baltimore, MD 21244-8013.</P>
            <P>Please allow sufficient time for mailed comments to be received before the close of the comment period.</P>
            <P>3.<E T="03">By express or overnight mail.</E>You may send written comments to the following address only:Centers for Medicare &amp; Medicaid Services,Department of Health and Human Services,Attention: CMS-1582-PN,Mail Stop C4-26-05,7500 Security Boulevard,Baltimore, MD 21244-1850.</P>
            <P>4.<E T="03">By hand or courier.</E>If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses:</P>
            <P>a. For delivery in Washington, DC—Centers for Medicare &amp; Medicaid Services,Department of Health and Human Services,Room 445-G, Hubert H. Humphrey Building,200 Independence Avenue, SW.,Washington, DC 20201.</P>
            <P>(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)</P>
            <P>b. For delivery in Baltimore, MD—Centers for Medicare &amp; Medicaid Services,Department of Health and Human Services,7500 Security Boulevard,Baltimore, MD 21244-1850.</P>
            <P>If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.</P>
            <P>Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.</P>

            <P>For information on viewing public comments, see the beginning of the<E T="02">SUPPLEMENTARY INFORMATION</E>section.</P>
          </ADD>
          <FURINF>
            <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
            <P>Erin Smith, (410) 786-4497, for issues related to physician payment and for all other issues not identified below.</P>
            <P>Elizabeth Truong, (410) 786-6005, or Sara Vitolo, (410) 786-5714, for issues related to work RVUs.</P>
            <P>Ryan Howe, (410) 786-3355, for issues related to PE RVUs.</P>
          </FURINF>
        </PREAMB>
        <SUPLINF>
          <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
          <P/>
          <P SOURCE="NPAR">
            <E T="03">Inspection of Public Comments:</E>All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received:<E T="03">http://regulations.gov.</E>Follow the search instructions on that Web site to view public comments.</P>
          <P>Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare &amp; Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.</P>
          <HD SOURCE="HD1">Table of Contents</HD>
          <EXTRACT>
            <FP SOURCE="FP-2">I. Background</FP>
            <FP SOURCE="FP1-2">A. History</FP>
            <FP SOURCE="FP1-2">B. Physician Fee Schedule Rulemaking</FP>
            <FP SOURCE="FP1-2">C. The Five-Year Review Process</FP>
            <FP SOURCE="FP1-2">1. Identification of CPT Codes for Review</FP>
            <FP SOURCE="FP1-2">2. Background on American Medical Association/Specialty Society Relative Value Update Committee (AMA RUC) Recommendations AMA RUC</FP>
            <FP SOURCE="FP1-2">3. Five-Year Review of Work Process</FP>
            <FP SOURCE="FP-2">II. CMS Review of Five-Year Review Codes</FP>
            <FP SOURCE="FP1-2">A. CMS Analytical Approach</FP>
            <FP SOURCE="FP1-2">B. Summary of Proposed Work RVUs for Five-Year Review Codes</FP>
            <FP SOURCE="FP1-2">C. Code-Specific Discussions of Proposed Alternative Work RVUs</FP>
            <FP SOURCE="FP1-2">1. Drainage of Hematoma</FP>
            <FP SOURCE="FP1-2">2. Wound Repair</FP>
            <FP SOURCE="FP1-2">3. Skin Grafts</FP>
            <FP SOURCE="FP1-2">4. Destruction of Skin Lesions</FP>
            <FP SOURCE="FP1-2">5. Partial Mastectomy</FP>
            <FP SOURCE="FP1-2">6. Percutaneous Vertebroplasty/Kyphoplasty</FP>
            <FP SOURCE="FP1-2">7. Closed Treatment of Distal Radial Fracture</FP>
            <FP SOURCE="FP1-2">8. Orthopaedic Surgery—Thigh/Knee</FP>
            <FP SOURCE="FP1-2">9. Treatment of Ankle Fracture</FP>
            <FP SOURCE="FP1-2">10. Orthopaedic Surgery/Podiatry</FP>
            <FP SOURCE="FP1-2">11. Application of Cast and Strapping</FP>
            <FP SOURCE="FP1-2">12. Cardiothoracic Surgery</FP>
            <FP SOURCE="FP1-2">13. Vascular Surgery</FP>
            <FP SOURCE="FP1-2">14. Excise Parotid Gland/Lesion</FP>
            <FP SOURCE="FP1-2">15. Endoscopic Cholangiopancreatography</FP>
            <FP SOURCE="FP1-2">16. Sigmoidoscopy</FP>
            <FP SOURCE="FP1-2">17. Laparoscopic Cholecystectomy</FP>
            <FP SOURCE="FP1-2">18. Hernia Repair</FP>
            <FP SOURCE="FP1-2">19. Laparoscopic Hernia Repair</FP>
            <FP SOURCE="FP1-2">20. Urologic Procedures</FP>
            <FP SOURCE="FP1-2">21. Removal of Thyroid/Parathyroid</FP>
            <FP SOURCE="FP1-2">22. Implant Neuroelectrodes</FP>
            <FP SOURCE="FP1-2">23. Injection of Anesthetic Agent</FP>
            <FP SOURCE="FP1-2">24. Gastric Emptying Study</FP>
            <FP SOURCE="FP1-2">25. Nasopharyngoscopy</FP>
            <FP SOURCE="FP1-2">26. Cardiopulmonary Resuscitation</FP>
            <FP SOURCE="FP1-2">27. Osteopathic Manipulative Treatment</FP>
            <FP SOURCE="FP1-2">28. Observation Care</FP>
            <FP SOURCE="FP1-2">D. HCPAC-Recommended Work RVUs—Excision of Nail</FP>
            <FP SOURCE="FP1-2">E. CPT Codes Identified Through the Five-Year Review Process, But Not Reviewed by CMS</FP>
            <FP SOURCE="FP1-2">1. CPT Codes Referred to CPT Editorial Board</FP>

            <FP SOURCE="FP1-2">2. CPT Codes Withdrawn From the Five-Year Review<PRTPAGE P="32411"/>
            </FP>
            <FP SOURCE="FP1-2">3. CPT Codes That Are Interim Final for CY 2011</FP>
            <FP SOURCE="FP1-2">4. CPT Codes for Preventive Medicine Services</FP>
            <FP SOURCE="FP1-2">F. Resource-Based Practice Expense RVUs</FP>
            <FP SOURCE="FP1-2">1. Overview</FP>
            <FP SOURCE="FP1-2">2. Practice Expense Methodology</FP>
            <FP SOURCE="FP1-2">a. Direct Practice Expense</FP>
            <FP SOURCE="FP1-2">b. Indirect Practice Expense per Hour Data</FP>
            <FP SOURCE="FP1-2">c. Allocation of Practice Expense to Services</FP>
            <FP SOURCE="FP1-2">d. Facility and Nonfacility Costs</FP>
            <FP SOURCE="FP1-2">e. Services With Technical Components and Professional Components</FP>
            <FP SOURCE="FP1-2">f. Practice Expense RVU Methodology</FP>
            <FP SOURCE="FP1-2">3. Practice Expense RVUs for Codes Included in the Five-Year Review</FP>
            <FP SOURCE="FP1-2">a. Changes to Direct Practice Expense Inputs</FP>
            <FP SOURCE="FP1-2">(1) Changes in Intra-Service Physician Time in the Nonfacility Setting</FP>
            <FP SOURCE="FP1-2">(2) Changes in Hospital Discharge Management Services in the Facility Setting</FP>
            <FP SOURCE="FP1-2">(3) Changes in the Number or Level of Postoperative Office Visits in the Global Period</FP>
            <FP SOURCE="FP1-2">b. Changes in Components of the Indirect Practice Expense Methodology</FP>
            <FP SOURCE="FP1-2">(1) Work RVUs, Direct PE RVUs, and Clinical Labor PE RVUs</FP>
            <FP SOURCE="FP1-2">(2) Physician Time</FP>
            <FP SOURCE="FP1-2">G. Malpractice RVUs</FP>
            <FP SOURCE="FP-2">III. Budget Neutrality</FP>
            <FP SOURCE="FP-2">IV. Collection of Information Requirements</FP>
            <FP SOURCE="FP-2">V. Regulatory Impact Analysis</FP>
            <FP SOURCE="FP1-2">A. Overall Impact</FP>
            <FP SOURCE="FP1-2">B. Anticipated Effects: Impact on Beneficiaries</FP>
            <FP SOURCE="FP1-2">C. Alternatives Considered</FP>
            <FP SOURCE="FP1-2">D. Accounting Statement and Table</FP>
            <FP SOURCE="FP1-2">E. Conclusion</FP>
            <FP SOURCE="FP-2">Addendum A: Explanation and Use of Addendum B</FP>
            <FP SOURCE="FP-2">Addendum B: Relative Value Units and Related Information</FP>
            <FP SOURCE="FP-2">Addendum C: Codes With Work RVUs Subject to Comment</FP>
          </EXTRACT>
          
          <P>In addition, because of the many organizations and terms to which we refer by acronym in this proposed notice, we are listing these acronyms and their corresponding terms in alphabetical order below:</P>
          
          <EXTRACT>
            <FP SOURCE="FP-1">AADAmerican Academy of Dermatology</FP>
            <FP SOURCE="FP-1">AANAmerican Academy of Neurology</FP>
            <FP SOURCE="FP-1">AANEMAmerican Association of Neuromuscular and Electrodiagnostic Medicine</FP>
            <FP SOURCE="FP-1">AAFPAmerican Academy of Family Physicians</FP>
            <FP SOURCE="FP-1">AAGPAmerican Association for Geriatric Psychiatry</FP>
            <FP SOURCE="FP-1">AAHCPAmerican Academy of Home Care Physicians</FP>
            <FP SOURCE="FP-1">AANSAmerican Association of Neurological Surgeons</FP>
            <FP SOURCE="FP-1">AAOAmerican Academy of Ophthalmology</FP>
            <FP SOURCE="FP-1">AAO-HNSAmerican Academy of Otolaryngology—Head and Neck Surgery</FP>
            <FP SOURCE="FP-1">AAOAAmerican Academy of Otolaryngic Allergy</FP>
            <FP SOURCE="FP-1">AAOSAmerican Academy of Orthopaedic Surgeons</FP>
            <FP SOURCE="FP-1">AAPAmerican Academy of Pediatrics</FP>
            <FP SOURCE="FP-1">AAPMAmerican Academy of Pain Medicine</FP>
            <FP SOURCE="FP-1">AAPMRAmerican Academy of Physical Medicine and Rehabilitation</FP>
            <FP SOURCE="FP-1">AATSAmerican Association for Thoracic Surgery</FP>
            <FP SOURCE="FP-1">ACCAmerican College of Cardiology</FP>
            <FP SOURCE="FP-1">ACGAmerican College of Gastroenterology</FP>
            <FP SOURCE="FP-1">ACNSAmerican Clinical Neurophysiology Society</FP>
            <FP SOURCE="FP-1">ACOGAmerican College of Obstetricians and Gynecologists</FP>
            <FP SOURCE="FP-1">ACRAmerican College of Radiology</FP>
            <FP SOURCE="FP-1">ACSAmerican College of Surgeons</FP>
            <FP SOURCE="FP-1">AFROCAssociation of Freestanding Radiation Oncology Centers</FP>
            <FP SOURCE="FP-1">AGAAmerican Gastroenterological Association</FP>
            <FP SOURCE="FP-1">AGSAmerican Geriatric Society</FP>
            <FP SOURCE="FP-1">AKActinic keratoses</FP>
            <FP SOURCE="FP-1">AMAAmerican Medical Association</FP>
            <FP SOURCE="FP-1">AMDAAmerican Medical Directors Association</FP>
            <FP SOURCE="FP-1">AOAAmerican Optometric Association</FP>
            <FP SOURCE="FP-1">ASAAmerican Society of Anesthesiologists</FP>
            <FP SOURCE="FP-1">ASCAmbulatory surgical center</FP>
            <FP SOURCE="FP-1">ASCRSAmerican Society of Colon and Rectal Surgeons</FP>
            <FP SOURCE="FP-1">ASGEAmerican Society of Gastrointestinal Endoscopy</FP>
            <FP SOURCE="FP-1">ASHAAmerican Speech-Language-Hearing Association</FP>
            <FP SOURCE="FP-1">ASPSAmerican Society of Plastic Surgeons</FP>
            <FP SOURCE="FP-1">ASSHAmerican Society for Surgery of the Hand</FP>
            <FP SOURCE="FP-1">ASTROAmerican Society for Therapeutic Radiology and Oncology</FP>
            <FP SOURCE="FP-1">AUAAmerican Urological Association</FP>
            <FP SOURCE="FP-1">BBA 97Balanced Budget Act of 1997 (Pub. L. 105-33)</FP>
            <FP SOURCE="FP-1">BBRA[Medicare, Medicaid and State Child Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)</FP>
            <FP SOURCE="FP-1">BNFBudget neutrality factor</FP>
            <FP SOURCE="FP-1">CAPUCoalition for the Advancement of Prosthetic Urology</FP>
            <FP SOURCE="FP-1">CFConversion factor</FP>
            <FP SOURCE="FP-1">CNSCongress of Neurological Surgeons</FP>
            <FP SOURCE="FP-1">CPEPClinical Practice Expert Panels</FP>
            <FP SOURCE="FP-1">CPTCurrent Procedural Terminology</FP>
            <FP SOURCE="FP-1">CYCalendar year</FP>
            <FP SOURCE="FP-1">DRGDiagnosis-Related Group</FP>
            <FP SOURCE="FP-1">E/MEvaluation and management</FP>
            <FP SOURCE="FP-1">FR<E T="04">Federal Register</E>
            </FP>
            <FP SOURCE="FP-1">HCPACHealth Care Professionals Advisory Committee</FP>
            <FP SOURCE="FP-1">HCPCSHealthcare Common Procedure Coding System</FP>
            <FP SOURCE="FP-1">HHSHealth and Human Services</FP>
            <FP SOURCE="FP-1">ICUIntensive care unit</FP>
            <FP SOURCE="FP-1">IDTFIndependent diagnostic testing facility</FP>
            <FP SOURCE="FP-1">IWPUTIntra-service work per unit of time</FP>
            <FP SOURCE="FP-1">JCAAIJoint Council of Allergy, Asthma, and Immunology</FP>
            <FP SOURCE="FP-1">MMAMedicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)</FP>
            <FP SOURCE="FP-1">MMSVMinimum multi-specialty visit</FP>
            <FP SOURCE="FP-1">MPC[the RUC's] Multi-Specialty Points of Comparison</FP>
            <FP SOURCE="FP-1">NCQDISNational Coalition of Quality Diagnostic Imaging Services</FP>
            <FP SOURCE="FP-1">NPWPNon-physician work pool</FP>
            <FP SOURCE="FP-1">NSQIPNational Surgical Quality Improvement Program</FP>
            <FP SOURCE="FP-1">PCProfessional component</FP>
            <FP SOURCE="FP-1">PEPractice Expense</FP>
            <FP SOURCE="FP-1">PE/HRPractice expense per hour</FP>
            <FP SOURCE="FP-1">PEACPractice Expense Advisory Committee</FP>
            <FP SOURCE="FP-1">PERCPractice Expense Review Committee</FP>
            <FP SOURCE="FP-1">PFSPhysician fee schedule</FP>
            <FP SOURCE="FP-1">RFARegulatory Flexibility Act</FP>
            <FP SOURCE="FP-1">RIARegulatory impact analysis</FP>
            <FP SOURCE="FP-1">RNRegistered nurse</FP>
            <FP SOURCE="FP-1">RUC[AMA's Specialty Society] Relative [Value] Update Committee</FP>
            <FP SOURCE="FP-1">RVURelative value unit</FP>
            <FP SOURCE="FP-1">SMS[AMA's] Socioeconomic Monitoring System</FP>
            <FP SOURCE="FP-1">SNFSkilled nursing facility</FP>
            <FP SOURCE="FP-1">STSSociety of Thoracic Surgeons</FP>
            <FP SOURCE="FP-1">SVSSociety for Vascular Surgery</FP>
            <FP SOURCE="FP-1">TCTechnical component</FP>
            <FP SOURCE="FP-1">VA[Department of] Veteran Affairs</FP>
          </EXTRACT>
          <HD SOURCE="HD1">CPT (Current Procedural Terminology) Copyright Notice</HD>
          <P>Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2010 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable FARS/DFARS apply.</P>
          <HD SOURCE="HD1">I. Background</HD>
          <HD SOURCE="HD2">A. History</HD>
          <P>Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services.” Section 1848 of the Act contains three major elements: (1) A fee schedule for the payment of physicians' services; (2) a sustainable growth rate for the rates of increase in Medicare expenditures for physicians' services; and (3) limits on the amounts that nonparticipating physicians can charge beneficiaries. The Act requires that payments under the fee schedule be based on national uniform relative value units (RVUs) based on the resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense (PE), and malpractice expense. In order to establish physician work, PE, and malpractice expense RVUs, section 1848(c)(2)(K)(iii) of the Act (as added by section 3134 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) (hereinafter the “Affordable Care Act”) also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years.</P>

          <P>The statute also specifies a budget neutrality requirement. Specifically,<PRTPAGE P="32412"/>section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures under Part B for the year to differ more than $20 million from what it would have been in the absence of these changes. If this threshold is exceeded, we are required to make adjustments to preserve budget neutrality.</P>
          <HD SOURCE="HD2">B. Physician Fee Schedule Rulemaking</HD>

          <P>On an annual basis, we publish regulations relating to updates to the RVUs and revisions to the payment policies under the PFS. Most recently, in the calendar year (CY) 2011 PFS final rule with comment period that was published in the<E T="04">Federal Register</E>on November 29, 2010 (75 FR 73170) (hereinafter referred to as the CY 2011 PFS final rule with comment period), we finalized most of the CY 2010 interim physician work, PE, and malpractice RVUs; issued new interim work, PE, and malpractice RVUs for new and revised codes for CY 2011; and finalized several other payment policies related to the PFS. In the January 11, 2011<E T="04">Federal Register</E>(76 FR 1670), we published a correction notice that identified and corrected a number of technical and typographical errors in the CY 2011 PFS final rule with comment period. The provisions of the correction notice were effective January 1, 2010.</P>
          <P>As noted previously, section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. We implemented the PFS effective for services furnished beginning January 1, 1992. The First Five-Year Review of Work was initiated in December 1994, and was effective for services furnished beginning January 1, 1997. The Second Five-Year Review of Work was initiated in November 1999, and was effective for services furnished beginning January 1, 2002. The Third Five-Year Review of Work was initiated in November 2004, and was effective for services furnished beginning January 1, 2007. The Fourth Five-Year Review of Work, the subject of this proposed notice, was initiated in November 2009 and will be effective for services furnished beginning January 1, 2012.</P>
          <P>This proposed notice describes the Fourth Five-Year Review of Work and sets forth proposed revisions to work RVUs resulting from the latest Review. This proposed notice also sets forth corresponding proposed changes to PE and malpractice RVUs affecting payment for physicians' services. Proposed revisions of physician work RVUs in this proposed notice and corresponding proposed changes to the PE and malpractice RVUs are subject to a 60-day public comment period. We will review public comments, make adjustments to our proposals in response to comments, as appropriate, and include final values in the CY 2012 PFS final rule with comment period, effective for services furnished beginning January 1, 2012.</P>
          <P>We note that with each PFS rule, we provide a summary table (“Addendum B”) of physician work, PE, and malpractice RVUs by HCPCS code for all services under the PFS. For this proposed notice, to create Addendum B, we retained the current CY 2011 RVUs for most codes and displayed new RVUs for only those codes involved in the Fourth Five-Year Review of Work. PE RVUs for these Five-Year Review codes were calculated using CY 2009 Medicare PFS utilization data in order to maintain consistency with the current CY 2011 RVUs displayed for all other services.</P>
          <P>We note that the Addendum B that will appear in the upcoming CY 2012 PFS proposed rule, where the annual updates to the RVUs and revisions to the payment policies under the PFS are customarily proposed, will include PE RVUs recalculated using the most recently available Medicare PFS utilization data and reflect other changes that would result from proposed revisions to PFS payment policies for CY 2012 that also would be effective beginning January 1, 2012.</P>
          <HD SOURCE="HD2">C. The Five-Year Review Process</HD>
          <HD SOURCE="HD3">1. Identification of CPT Codes for Review</HD>

          <P>We initiated the Fourth Five-Year Review of Work by soliciting public comments in the CY 2010 PFS final rule with comment period that was published in the<E T="04">Federal Register</E>on November 25, 2009 (74 FR 61738 and 61941) on potentially misvalued codes for all services. In response to our solicitation of potentially misvalued codes, we received comments from approximately 16 specialty groups, organizations, and individuals involving 113 Current Procedural Terminology (CPT) codes. Ten additional codes were submitted by the Medicare contractor medical directors (CMDs). Furthermore, CMS identified 96 services that we believed should be reviewed as part of the Fourth Five-Year Review of Work. These services fall within the two categories described in the CY 2010 PFS final rule with comment period: (1) Codes that were not previously reviewed by the AMA RUC, specifically, Harvard-valued codes with an annual utilization of &gt; 30,000 services, and (2) codes that are valued as being performed in the inpatient setting, but that are now performed predominantly on an outpatient basis (codes with Site-of-Service anomalies). For Site-of-Service anomaly codes, we also applied additional selection criteria. Specifically, the codes we selected for the Fourth Five-Year Review of Work contained at least one inpatient hospital visit in their value and the most recently available Medicare PFS claims data at that time showed annual allowed charges of greater than $1 million.</P>
          <P>The following tables list the codes identified for the Fourth Five-Year Review of Work.</P>
          <BILCOD>BILLING CODE P</BILCOD>
          <GPH DEEP="410" SPAN="3">
            <PRTPAGE P="32413"/>
            <GID>EP06JN11.000</GID>
          </GPH>
          <GPH DEEP="611" SPAN="3">
            <PRTPAGE P="32414"/>
            <GID>EP06JN11.001</GID>
          </GPH>
          <GPH DEEP="608" SPAN="3">
            <PRTPAGE P="32415"/>
            <GID>EP06JN11.002</GID>
          </GPH>
          <GPH DEEP="601" SPAN="3">
            <PRTPAGE P="32416"/>
            <GID>EP06JN11.003</GID>
          </GPH>
          <GPH DEEP="601" SPAN="3">
            <PRTPAGE P="32417"/>
            <GID>EP06JN11.004</GID>
          </GPH>
          <GPH DEEP="604" SPAN="3">
            <PRTPAGE P="32418"/>
            <GID>EP06JN11.005</GID>
          </GPH>
          <GPH DEEP="278" SPAN="3">
            <PRTPAGE P="32419"/>
            <GID>EP06JN11.006</GID>
          </GPH>
          <BILCOD>BILLING CODE P</BILCOD>
          <HD SOURCE="HD3">2. Background on American Medical Association Specialty Society Relative Value Update Committee (AMA RUC) Recommendations</HD>
          <P>Section 1848(c)(2)(K)(iii) of the Act (as added by section 3134 of the Affordable Care Act) specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In accordance with section 1848(c)(2)(K)(iii) of the Act, we develop and propose appropriate adjustments to the RVUs, taking into account the recommendations provided by the AMA RUC, the Medicare Payment Advisory Commission (MedPAC), and others. To respond to concerns expressed by MedPAC, the Congress, and other stakeholders regarding the accuracy of values for services under the PFS, the AMA RUC has used an annual process to systematically identify, review, and provide CMS with recommendations for revised work values for many existing potentially misvalued services. In addition to providing recommendations to CMS for work RVUs, the AMA RUC also reviews direct PE (clinical labor, medical supplies, and medical equipment) for individual services and examines the many broad methodological issues relating to the development of PE RVUs.</P>
          <P>For many years, the AMA RUC has provided CMS with recommendations on the appropriate relative values for PFS services. The AMA RUC's recommendations on physician work RVUs have resulted in significant refinements in physician work RVUs over the years. In recent years CMS and the AMA RUC have taken increasingly significant steps to address potentially misvalued codes. As MedPAC noted in its March 2009 Report to Congress, in the intervening years since MedPAC made the initial recommendations, “CMS and the AMA RUC have taken several steps to improve the review process.” In addition to the Five-Year Reviews of Work, over the past several years CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens for codes at risk for being misvalued, such as codes with high growth rates, codes that are frequently billed together in one encounter, and codes that are valued as inpatient services but that are now predominantly performed as outpatient services. This annual review of work RVUs and direct PE inputs for potentially misvalued codes was further bolstered by the Affordable Care Act mandate to examine potentially misvalued codes, with an emphasis on the following categories specified in section 1848(c)(2)(K)(ii) (as added by section 3134 of the Affordable Care Act):</P>
          <P>• Codes and families of codes for which there has been the fastest growth.</P>
          <P>• Codes or families of codes that have experienced substantial changes in practice expenses.</P>
          <P>• Codes that are recently established for new technologies or services.</P>
          <P>• Multiple codes that are frequently billed in conjunction with furnishing a single service.</P>
          <P>• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.</P>
          <P>• Codes which have not been subject to review since the implementation of the RBRVS (the `Harvard valued codes').</P>
          <P>• Other codes determined to be appropriate by the Secretary. (For example, codes for which there have been shifts in the Site-of-Service (Site-of-Service anomalies), as well as codes that qualify as “23-hour stay” outpatient services.)</P>
          <P>As a result of the annual potentially misvalued code review, CMS has reviewed over 700 codes for work and PE RVU changes outside of the comprehensive Five-Year Review process over the past several years and adopted appropriate work RVUs and direct PE inputs for these services in the context of contemporary medical practice.</P>

          <P>This Fourth Five-Year Review of Work advances the progress of our initiative to examine potentially misvalued codes by identifying and reviewing additional codes for CY 2012 in several of the categories specified in the Affordable Care Act, including a number of Harvard-valued codes. As<PRTPAGE P="32420"/>noted previously, we typically discuss the potentially misvalued codes initiative in the annual PFS proposed and final rules (for CY 2011, at 75 FR 40065 through 40082 and 75 FR 73215 through 73216, respectively). For example, we provided a detailed discussion of the prior reviews of potentially misvalued codes in the CY 2011 PFS final rule with comment period (75 FR 73215 through 73216). Furthermore, in addition to the proposals in this Five-Year Review of Work proposed notice, we plan to continue our work examining potentially misvalued codes for CY 2012 in the areas specified by the Affordable Care Act and others identified by the Secretary, consistent with the new legislative mandate on this issue. We will provide a comprehensive update regarding our progress to date in evaluating and revising the values for potentially misvalued codes, and discuss our priorities and future plans to ensure the accuracy of the relative values for all services paid under the PFS in the forthcoming CY 2012 PFS proposed rule.</P>
          <P>We greatly appreciate the considerable sustained efforts made by all members and staff of the AMA RUC to date, and we look forward to continuing our collaborative work with the AMA RUC toward our mutual goal of ensuring that CPT codes are appropriately valued under the PFS.</P>
          <P>For codes used primarily by nonphysician practitioners, the Health Care Professionals Advisory Committee (HCPAC), a deliberative body of nonphysician practitioners that also convenes during the AMA RUC meeting, submits recommendations directly to CMS. The HCPAC represents physician assistants, chiropractors, nurses, occupational therapists, optometrists, physical therapists, podiatrists, psychologists, audiologists, speech pathologists, social workers, and registered dieticians. We greatly appreciate the efforts of the HCPAC as well.</P>
          <HD SOURCE="HD3">3. AMA RUC Five-Year Review of Work Process</HD>
          <P>After compiling the list of potentially misvalued codes to be reviewed in the Fourth Five-Year Review of Work (Tables 1 through 4), we submitted the list to the AMA RUC.</P>
          <P>According to the AMA RUC's Five-Year Review timetable, upon receipt of the list of codes from CMS, the AMA RUC sent Level of Interest (LOI) forms to all specialty societies and the HCPAC so that the Five-Year Review codes could be reviewed initially by the appropriate specialty societies. To prepare for presentations of the codes to the AMA RUC, most specialty societies compiled data using a standard survey instrument whereby respondents compared the surveyed service with similar “reference” services for which there generally are well-established work values. Respondents were asked to estimate: the work RVU for the survey code; the time to perform the “pre-”, “intra-”, and “post-” service activities; and the technical skill, risk, and judgment involved with performing the service. Post-service activities were broken down into hospital and office visits and were assigned an appropriate evaluation and management (E/M) code by the respondents for the typical service. Each specialty society was responsible for selecting the physician sample size to be surveyed. In general, a minimum of 30 responses was required by the AMA RUC for the survey to be considered adequate. It is our understanding that the AMA RUC is currently reviewing its survey methodologies in order to improve the survey instrument's ability to provide valid and reliable data.</P>
          <P>As part of the AMA RUC's process, the specialty societies also provided the AMA RUC with a work RVU recommendation for each code under review. The AMA RUC met to hear the presentations from the specialty societies for each code, deliberate as a group, and vote on the work RVU, physician times, PE direct inputs (if applicable), and other aspects pertaining to the valuation of a code. The AMA RUC then sent its recommendations to CMS. As we have stated previously in conducting Five-Year Reviews, we retain the responsibility for analyzing any comments and recommendations received from the AMA RUC, developing the proposed notice, evaluating the comments on the proposed notice, and deciding whether and how to revise the work RVUs for any given service.</P>
          <HD SOURCE="HD1">II. CMS Review of Five-Year Review Codes</HD>
          <HD SOURCE="HD2">A. CMS Analytical Approach</HD>
          <P>We conducted a clinical review of each code and reviewed the AMA RUC recommendations for work RVU, time to perform the “pre-”, “intra-”, and “post-” service activities, as well as other components of the service which contribute to the value. Our clinical review generally includes, but is not limited to, a review of information provided by the AMA RUC, medical literature, public comments, and comparative databases, as well as a comparison with other codes within the Medicare PFS, consultation with other physicians and healthcare care professionals within CMS and the Federal Government, and the clinical experience of the physicians on the clinical team. We also assessed the methodology and data used to develop the recommendations and the rationale for the recommendations. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), the AMA RUC uses a variety of methodologies and approaches to assign work RVUs, including building block, survey data, crosswalk to key reference or similar codes, and magnitude estimation. The resource-based relative value system (RBRVS) has incorporated into it cross-specialty and cross-organ system relativity. This RBRVS requires assessment of relative value and takes into account the clinical intensity and time required to perform a service. In selecting which methodological approach will best determine the appropriate value for a service we consider the current physician work and time values, AMA RUC recommended physician work and time values, and specialty society physician work and time values, as well as the intensity of the service, all relative to other services. In general, if we had concerns regarding the AMA RUC's application of a particular methodology for a code, we assessed whether the recommended work RVUs were appropriate by using alternative methodologies. For a full discussion of our views and concerns regarding the various methodologies, we refer readers to the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329). During our clinical review to assess the appropriate values for the codes included in the Fourth Five-Year Review, several recurring scenarios emerged. We developed systematic approaches to address two particular areas of concern.</P>

          <P>The first area of concern pertains to codes with Site-of-Service anomalies. These are codes that were originally valued as inpatient services but current Medicare PFS claims data show they are furnished predominantly as outpatient services. We noted that for nearly all of the codes with Site-of-Service anomalies, the accompanying survey data suggest they are “23 hour stay” outpatient services. We discussed in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227) the “23 hour stay service,” which is a term of art describing services that typically have lengthy hospital outpatient recovery periods. For these 23 hour stay services, the typical patient is commonly at the hospital for less than<PRTPAGE P="32421"/>24 hours, but often stays overnight at the hospital. For example, if the patient arrives at the hospital at 6 a.m. for a scheduled surgical procedure that typically has a lengthy hospital outpatient recovery period, the patient may recover during the day and be ready to be discharged late in the evening without having to stay overnight at the hospital. More commonly, however, if the patient arrives at the hospital at noon for a surgical procedure that typically has a lengthy hospital outpatient recovery period, the patient may stay at the hospital overnight to recover and be discharged the following morning. On occasion, the patient may recover at the hospital for longer than a single night, either because the patient requires an even longer recovery period or the surgery was performed outside of usual business hours. For example, if the patient arrives at the hospital at 11 p.m. and requires an unscheduled surgical procedure that typically has a lengthy hospital outpatient recovery period, the patient may stay at the hospital overnight in preparation for surgery, have the surgical procedure performed, and then stay through another night recovering at the hospital before being discharged. In all these cases, unless a treating physician has written an order to admit the patient as an inpatient, the patient is considered for Medicare purposes to be a hospital outpatient, not an inpatient, and our claims data support that the typical 23 hour stay service is billed as an outpatient service.</P>
          <P>We believe that the values of the codes that fall into the 23 hour stay category, that is, services that typically have lengthy hospital outpatient recovery periods, should not reflect work that is typically associated with an inpatient service. For example, inpatient E/M visit codes such as CPT codes 99231 (Level 1 subsequent hospital care, per day); 99232 (Level 2 subsequent hospital care, per day); and 99233 (Level 3 subsequent hospital care, per day), should not be included at their full RVU value in the valuation of these services that typically have lengthy hospital outpatient recovery periods. However, as we stated in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227), we find it is plausible that while the patient receiving the outpatient 23 hour stay service remains a hospital outpatient, the patient would typically be cared for by a physician during that lengthy recovery period at the hospital. While we do not believe that post-procedure hospital visits would be at the inpatient level since the typical case is an outpatient who would be ready to be discharged from the hospital in 23 hours or less, we believe it is generally appropriate to include the intra-service time of the inpatient hospital visit in the immediate post-service time of the 23 hour stay code under review. In addition, we indicated that we believe it is appropriate to include a half day, rather than a full day, of a discharge day management service. While some commenters advocated for a deferral on the issue of valuing 23 hour stay services, we note that a number of commenters supported CMS' approach. Consequently, we finalized this policy in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227) and encouraged the AMA RUC to apply this methodology in developing the recommendations it provides to us for valuing 23 hour stay codes, in order to ensure the consistent and appropriate valuation of the physician work for these services.</P>
          <P>The AMA RUC reviewed a number of Site-of-Service anomaly codes during its February 2011 meeting, many of which are Site-of-Service anomaly codes that have been valued on an interim basis since CY 2009. These Site-of-Service anomaly codes typically have a lengthy hospital outpatient recovery period and thus would be subject to the policy previously described for valuing the post-procedure physician care. CMS had requested that the AMA RUC re-review them due to concerns over the methodology the AMA RUC used originally in valuing these codes (74 FR 61777 and 75 FR 73221). Contrary to the 23 hour stay policy we finalized in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227), as described above, in the AMA RUC's review of Site-of-Service anomaly codes for CY 2012 as part of this Five-Year Review, the AMA RUC often recommended replacing the hospital inpatient post-operative visit blocks in the current work values with blocks for subsequent observation care services, specifically CPT codes 99224 (Level 1 subsequent observation care, per day) and 99225 (Level 2 subsequent observation care, per day), which recently became effective under the PFS beginning in CY 2011. The AMA RUC stated in its summary recommendations to CMS, “Adjustments to the allocation of post-operative visits are used as proxies and do not constitute changes to the physician work relative value of the service which was determined by magnitude estimation and physician specialty survey data during the last RUC review.” However, we note that the AMA RUC generally recommended maintaining the current interim value of the CY 2009 Site-of-Service anomaly codes while replacing the inpatient hospital visit code blocks with subsequent observation care code blocks.</P>
          <P>We continue to be concerned over the AMA RUC's approach to valuing the physician work for these Site-of-Service anomaly codes. We believe the appropriate methodology entails accounting for the removal of the inpatient visit blocks in the work value for the Site-of-Service anomaly code since these services are no longer typically furnished in the inpatient setting. We do not believe it is appropriate to simply exchange the inpatient post-operative visits in the original value with subsequent observation care visits (which are appropriately reported in cases of nonsurgical hospital outpatient stays spanning 3 calendar days or longer), and maintain the current work RVUs. Furthermore, instead of the half discharge day management service included in past recommendations (CPT code 99238 (Hospital discharge day management; 30 minutes or less)), the AMA RUC generally recommended including a full observation care discharge day management service (CPT code 99217 (Observation care discharge day management (this code is to be utilized by the physician to report all services provided to a patient on discharge from “observation status” if the discharge is on other than the initial date of “observation status.”))) However, the AMA RUC indicated it is currently assessing this code to revise the physician times. We do not believe it is appropriate to substitute a full day of CPT code 99217 for the half day of CPT code 99238 that would be included in the work value for a Site-of-Service anomaly code according to CMS' established policy, especially given the AMA RUC's ongoing review of CPT code 99217.</P>

          <P>Accordingly, where the data suggested a Site-of-Service anomaly code (more than 50 percent of the most recent Medicare utilization is outpatient—based on PFS data from the fourth quarter of CY 2009 and the first three quarters of CY 2010 to represent the most recent full 12 months of claims data available) resembles a 23 hour stay outpatient service and the AMA RUC's recommended value from the Five-Year Review continued to include inpatient visits (or subsequent observation care codes) in the post-operative period, we applied the policy described above. That is, we consistently removed any post-procedure inpatient visits or subsequent observation care services<PRTPAGE P="32422"/>included in the AMA RUC-recommended values for these codes and adjusted physician times accordingly. We also consistently included the value of a half day of a discharge management service.</P>
          <P>An additional concern that arose in our clinical review of the codes relates to codes that are typically billed with an E/M service on the same day. The AMA RUC noted for a number of codes that the service was typically billed with an additional E/M service on the same day; however, it appears the AMA RUC did not consistently account for this overlap in formulating its time recommendations, an issue discussed on a CPT code-specific basis below. In cases where a service is typically furnished with an E/M service on the same day, we believe it is understood that there may be overlap between the two services in some of the activities conducted during the pre- and post-service times of the procedure code, and that these overlapping activities should not be counted twice. Accordingly, in cases where the most recently available Medicare PFS claims data show the code is typically (greater than 50 percent of the time—based on PFS data from CY 2009) billed with an E/M visit on the same day, and where we believe that the AMA RUC did not adequately account for overlapping activities in the recommended value for the code, we systematically adjusted the physician times for the code to account for the overlap. After clinical review of the pre- and post-service work, we believe that at least<FR>1/3</FR>of the physician time in both the pre-service evaluation and post-service period is duplicative of the E/M visit in this circumstance. Therefore, we adjusted the pre-service evaluation portion of the pre-service time to<FR>2/3</FR>of the AMA RUC-recommended time. Similarly, we also adjusted the post-service time to<FR>2/3</FR>of the AMA RUC-recommended time.</P>
          <P>As noted in the CY 2011 proposed rule (75 FR 73328), in reviewing the AMA RUC recommendations for valuing the work of new, revised, and potentially misvalued services, we expend significant effort in evaluating whether the recommended values reflect the work elements, such as time, mental effort, and professional judgment, technical skill and physical effort, and stress due to risk, involved with furnishing the service. Subjecting each of the codes to a clinical review, we examined the pre-, post-, and intra-service components of the work. In cases where we disagreed with the AMA RUC's recommended work RVU, we proposed alternative values based on comparisons with other established reference codes with clinical similarity or analogous physician times, or the 25th percentile or low value as indicated in the physician survey, or, where applicable, employed the building block approach.</P>
          <P>Over the last several years our rate of acceptance of the AMA RUC recommendations has been higher. However, in response to concerns expressed by MedPAC, and other stakeholders regarding the accurate valuation of services under the PFS, we have intensified our scrutiny of the work valuations of new, revised, and potentially misvalued codes. We note that most recently, section 3134 of the Affordable Care Act added a new requirement, which specifies that the Secretary shall establish a formal process to validate RVUs under the PFS. The validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may include validation of the pre-, post-, and intra-service components of work. Furthermore, the Secretary is directed to validate a sampling of the work RVUs of codes identified through any of the seven categories of potentially misvalued codes specified by section 1848(c)(2)(K)(ii) of the Act (as added by section 3134 of the Affordable Care Act). While we are currently in the planning stage of developing a formal validation process, we have incorporated, where appropriate, the validation principles specified in the law in this Five-Year Review process.</P>
          <HD SOURCE="HD2">B. Summary of Proposed Work RVUs for Five-Year Review Codes</HD>
          <P>As stated previously, we sent the AMA RUC an initial list of 219 codes for review. We have encouraged the AMA RUC to review codes on a “family” basis rather than in isolation in order to ensure that appropriate relativity in the system is retained. Consequently, the AMA RUC included additional codes for review, resulting in a total of 290 codes for the Fourth Five-Year Review of Work. Of those 290 codes, 53 were subsequently sent to the CPT Editorial Panel to consider coding changes, 14 were not reviewed by the AMA RUC (and subsequently not reviewed by CMS) because the specialty society that had originally requested the review in its public comments on the CY 2010 PFS final rule with comment period elected to withdraw the codes, 36 were not reviewed by the AMA RUC because their values were set as interim final in the CY 2011 PFS final rule with comment period, and 14 were not reviewed by CMS because they were noncovered services under Medicare. Therefore, the AMA RUC reviewed 173 of the 290 codes initially identified for this Fourth Five-Year Review of Work, and provided the recommendations to CMS that are addressed below in this proposed notice. A list of the remaining codes that were identified for possible review through the Five-Year Review process but not reviewed can be found in section II.E. of this proposed notice. Upon clinical review, we are proposing to accept 89 out of 173 (51 percent) of the AMA RUC recommendations for work RVUs. In some cases, we also refined physician times for codes as deemed appropriate to correspond with the proposed work RVUs. CMS' decisions are summarized in Table 6.</P>
          <P>In addition, the HCPAC submitted for CMS review its recommendations to modify work RVUs for five CPT codes under the Fourth Five-Year Review of Work. Of those five CPT codes, three were not reviewed by CMS because the codes were withdrawn by the relevant specialty society due to a low survey response rate. We did not accept the HCPAC recommendations for the two remaining CPT codes, as detailed in section II.D.1 of this proposed notice.</P>
          <BILCOD>BILLING CODE P</BILCOD>
          <GPH DEEP="232" SPAN="3">
            <PRTPAGE P="32423"/>
            <GID>EP06JN11.007</GID>
          </GPH>
          <GPH DEEP="598" SPAN="3">
            <PRTPAGE P="32424"/>
            <GID>EP06JN11.008</GID>
          </GPH>
          <GPH DEEP="598" SPAN="3">
            <PRTPAGE P="32425"/>
            <GID>EP06JN11.009</GID>
          </GPH>
          <GPH DEEP="598" SPAN="3">
            <PRTPAGE P="32426"/>
            <GID>EP06JN11.010</GID>
          </GPH>
          <GPH DEEP="598" SPAN="3">
            <PRTPAGE P="32427"/>
            <GID>EP06JN11.011</GID>
          </GPH>
          <GPH DEEP="307" SPAN="3">
            <PRTPAGE P="32428"/>
            <GID>EP06JN11.012</GID>
          </GPH>
          <GPH DEEP="305" SPAN="3">
            <GID>EP06JN11.013</GID>
          </GPH>
          <GPH DEEP="305" SPAN="3">
            <PRTPAGE P="32429"/>
            <GID>EP06JN11.014</GID>
          </GPH>
          <GPH DEEP="305" SPAN="3">
            <GID>EP06JN11.015</GID>
          </GPH>
          <GPH DEEP="305" SPAN="3">
            <PRTPAGE P="32430"/>
            <GID>EP06JN11.016</GID>
          </GPH>
          <GPH DEEP="305" SPAN="3">
            <GID>EP06JN11.017</GID>
          </GPH>
          <GPH DEEP="305" SPAN="3">
            <PRTPAGE P="32431"/>
            <GID>EP06JN11.018</GID>
          </GPH>
          <GPH DEEP="129" SPAN="3">
            <GID>EP06JN11.019</GID>
          </GPH>
          <BILCOD>BILLING CODE C</BILCOD>
          <HD SOURCE="HD2">C. Code-Specific Discussion of Proposed Alternative Work RVUs</HD>
          <HD SOURCE="HD3">1. Drainage of Hematoma</HD>
          <GPH DEEP="74" SPAN="3">
            <GID>EP06JN11.020</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 10140 and 10160 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen.</P>

          <P>For CPT code 10140 (Incision and drainage of hematoma, seroma or fluid collection), the AMA RUC reviewed the survey results and determined that these data support maintaining the current work RVU of 1.58 for this service. The AMA RUC believed that the current work RVU for CPT code 10140 is appropriate and recommended a work RVU of 1.58.<PRTPAGE P="32432"/>
          </P>
          <P>We agree with the AMA RUC-recommended work RVU for CPT code 10140 and are proposing a work RVU of 1.58 for CY 2012, with a refinement to the time. We believe the current pre-service evaluation time of 7 minutes is more appropriate than the AMA RUC-recommended pre-service evaluation time of 17 minutes. CPT code 10160 (Puncture aspiration of abscess, hematoma, bulla, or cyst) has the same description of typical pre-service evaluation work and an AMA RUC-recommended pre-service evaluation time of 7 minutes. After clinical review, we believe that 7 minutes accurately reflects the time required to conduct the pre-service evaluation work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">2. Wound Repair</HD>
          <GPH DEEP="310" SPAN="3">
            <GID>EP06JN11.021</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 12031, 12051, and 13101 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen. CPT codes 12032-12047, 12052-12057, and 13100 were added as part of the family of services for review. In its review of this set of CPT codes, the AMA RUC determined that the original Harvard values led to compression within these code families, which the AMA RUC recommended correcting by reducing the relative values for the smallest wound size repair codes and increasing the relative values for the larger wound size repair codes.</P>
          <P>In general, the specialty society surveys of physicians furnishing these intermediate wound repair codes confirmed that the work of performing these services had not changed in the past 5 years and that the complexity of patients requiring the services had also remained constant. Despite the survey findings, however, the survey median work RVUs were usually somewhat higher than the current work RVUs for the larger wound size repair codes. For many of these codes, the AMA RUC recommended the survey median values as the work RVUs for these wound repair services, despite its common recommendation of the survey 25th percentile values for codes in other families. In those cases discussed below where we disagreed with the AMA RUC recommendations, we based our proposed work RVU on the survey 25th percentile value, which was also usually higher than the current work RVU for the larger wound size repair codes. For the smaller wound size repair codes the AMA RUC recommended a lower work RVU than the current work RVU, and we agreed. In this way, our proposals for the revised work RVUs for the wound repair codes address concerns about compression in the original Harvard-valued work RVUs within the family. Our proposed range of work RVUs for intermediate wound repair codes in various body areas, while not as large as the range that would have resulted from our adoption of the AMA RUC's recommendations, nevertheless is greater than the current range of work RVUs for the variety of wound sizes described by the repair codes.</P>
          <P>For CPT code 12035 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); 12.6 cm to 20.0 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the survey median work RVU appropriately accounts for the work required for this service. The AMA RUC recommended a work RVU of 3.60 for CPT code 12035.</P>

          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12035 and believe that the survey 25th percentile value of a work RVU of 3.50 is more appropriate for this service. The majority of survey respondents<PRTPAGE P="32433"/>indicated that the work of performing this service has not changed in the past 5 years (79 percent), and that there has been no change in complexity among the patients requiring this service (82 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service and is consistent with the relativity adjustments recommended by the AMA RUC. Therefore, we are proposing an alternative work RVU of 3.50 for CPT code 12035 for CY 2012.</P>
          <P>For CPT code 12036 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); 20.1 cm to 30.0 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the survey median work RVU appropriately accounts for the work required for this service. The AMA RUC recommended a work RVU of 4.50 for CPT code 12036.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12036 and believe that the survey 25th percentile value of a work RVU of 4.23 is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (81 percent), and that there has been no change in complexity among the patients requiring this service (84 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service and is consistent with the relativity adjustments recommended by the AMA RUC. We are proposing an alternative work RVU of 4.23 for CPT code 12036 for CY 2012.</P>
          <P>In addition to the work RVU adjustment for CPT code 12036, we are refining the time associated with this code. We find an intra-service time of 70 minutes, the survey median, to be more appropriate than the AMA RUC-recommended intra-service time of 75 minutes. Per the survey, this time correctly captures the intra-service time differential between this CPT code and the key reference code. After clinical review, we believe that 70 minutes accurately reflects the time required to conduct the intra-service work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 12037 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); over 30.0 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the survey median work RVU appropriately accounts for the work required for this service. The AMA RUC recommended a work RVU of 5.25 for CPT code 12037.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12037 and believe that the survey 25th percentile value of a work RVU of 5.00 is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (81 percent), and that there has been no change in complexity among the patients requiring this service (83 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service and is consistent with the relativity adjustments recommended by the AMA RUC. Therefore, we are proposing an alternative work RVU of 5.00 for CPT code 12037 for CY 2012.</P>
          <P>For CPT code 12045 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 12.6 cm to 20.0 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the survey median work RVU appropriately accounts for the physician work required for this service. The AMA RUC recommended a work RVU of 3.90 for CPT code 12045.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12045 and believe that the survey 25th percentile value of a work RVU of 3.75 is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (80 percent), and that there has been no change in complexity among the patients requiring this service (80 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service and is consistent with the relativity adjustments recommended by the AMA RUC. Therefore, we are proposing an alternative work RVU of 3.75 for CPT code 12045 for CY 2012.</P>
          <P>For CPT code 12046 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 20.1 cm to 30.0 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the survey median work RVU appropriately accounts for the work required for this service. The AMA RUC recommended a work RVU of 4.60 for CPT code 12046.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12046 and believe that the survey 25th percentile value of a work RVU of 4.30 is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (79 percent), and that there has been no change in complexity among the patients requiring this service (79 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service. Therefore, we are proposing an alternative work RVU of 4.30 for CPT code 12046 for CY 2012.</P>
          <P>In addition to the work RVU adjustment for CPT code 12046, we are refining the time associated with this code. This service is typically performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. We believe that 9 minutes pre-service evaluation time and 9 minutes post-service time accurately reflect the time required to conduct the work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 12047 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; over 30.0 cm) the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined the survey median work RVU appropriately accounts for the work required for this service. The AMA RUC recommended a work RVU of 5.50 for CPT code 12046.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12047 and believe that the survey 25th percentile value of a work RVU of 4.95 is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (79 percent), and that there has been no change in complexity among the patients requiring this service (79 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service. Therefore, we are proposing an alternative work RVU of 4.95 for CPT code 12047 for CY 2012.</P>

          <P>In addition to the work RVU adjustment for CPT code 12047, we are refining the time associated with this code. Recent Medicare PFS claims data show that this service typically is performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore,<PRTPAGE P="32434"/>should not be counted twice in developing the procedure's work value. As described in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post service time by one-third. We believe that 9 minutes pre-service evaluation time and 10 minutes post-service time accurately reflect the time required to conduct the work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 12055 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 12.6 cm to 20.0 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the survey median work RVU appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 4.65 for CPT code 12055.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12055 and believe that the survey 25th percentile value of a work RVU of 4.50 is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (79 percent), and that there has been no change in complexity among the patients requiring this service (79 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service. Therefore, we are proposing an alternative work RVU of 4.50 for CPT code 12055 for CY 2012.</P>
          <P>In addition to the work RVU adjustment for CPT code 12055, we are refining the time associated with this code. We find an intra-service time of 60 minutes, the survey median and intra-service time of the key reference code, to be more appropriate than the AMA RUC-recommended intra-service time of 70 minutes. After clinical review, we believe that 60 minutes accurately reflects the time required to conduct the intra-service work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 12056 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 20.1 cm to 30.0 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the survey median work RVU appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 5.50 for CPT code 12056.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12056 and believe that the survey 25th percentile value of a work RVU of 5.30 is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (80 percent), and that there has been no change in complexity among the patients requiring this service (81 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service. Therefore, we are proposing an alternative work RVU of 5.30 for CPT code 12056 for CY 2012.</P>
          <P>In addition to the work RVU adjustment for CPT code 12056, we are refining the time associated with this code. We find an intra-service time of 70 minutes, the survey median, to be more appropriate than the AMA RUC-recommended intra-service time of 85 minutes. After clinical review, we believe that 70 minutes accurately reflects the time required to conduct the intra-service work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 12057 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; over 30.0 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the survey median work RVU appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 6.28 for CPT code 12057.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 12057 and believe that the survey 25th percentile value of a work RVU of 6.00 (the current value) is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (80 percent), and that there has been no change in complexity among the patients requiring this service (81 percent). We believe that the survey 25th percentile value accurately reflects the work associated with this service. Therefore, we are proposing an alternative work RVU of 6.00 for CPT code 12057 for CY 2012.</P>
          <P>In addition to the work RVU adjustment for CPT code 12057, we are refining the time associated with this code. We find an intra-service time of 90 minutes, the survey median, to be more appropriate than the AMA RUC-recommended intra-service time of 100 minutes. After clinical review, we believe that 90 minutes accurately reflects the time required to conduct the intra-service work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 13100 (Repair, complex, trunk; 1.1 cm to 2.5 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and agreed that the current work RVU of 3.17 maintains the appropriate relativity for this service. The AMA RUC recommended a work RVU of 3.17 for CPT code 13100.</P>
          <P>We note that the AMA RUC reviewed only two CPT codes in the complex wound repair family. While at this time we agree with the AMA RUC-recommended work RVU for CPT code 13100 and are proposing a work RVU of 3.17 for CY 2012, with a refinement to time, we request that, in order to ensure consistency, the AMA RUC review the entire set of codes in this family and assess the appropriate gradation of the work RVUs in this family. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (89 percent), and that there has been no change in complexity among the patients requiring this service (79 percent). We believe at this time that the current work RVU (3.17) and current times accurately reflect the service.</P>
          <P>For CPT code 13101 (Repair, complex, trunk; 2.6 cm to 7.5 cm), the AMA RUC reviewed the survey data from physicians who frequently perform this service and determined that the current work RVU of 3.96 maintains the appropriate relativity for this service. The AMA RUC recommended a work RVU of 3.96 for CPT code 13101. As we noted previously for the other complex wound code, at this time we agree with the AMA RUC-recommended work RVU for CPT code 13101 and are proposing a work RVU of 3.96 for CY 2012, with a refinement to time; however, we request that the AMA RUC review the entire set of codes in this family. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (94 percent), and that there has been no change in complexity among the patients requiring this service (79 percent). We believe that the current work RVU (3.96) and current times accurately reflect the service.</P>

          <P>We are proposing to accept the values for CPT codes 13100 and 13101 on an interim basis only, as we appreciate that the AMA RUC reviewed only two CPT codes in the complex wound repair family. We request that, in order to ensure consistency and appropriate gradation in value of work, the AMA RUC review all of the codes in this family. Specifically, we request that the<PRTPAGE P="32435"/>AMA RUC review the remaining codes in the complex wound repair family for CY 2013, and we would maintain the values for CPT codes 13100 and 13101 interim for CY 2012 while the AMA RUC completes its review of other codes in the family. For CY 2013, the revised work RVUs for all codes examined by the AMA RUC in the complex wound repair family, including CPT codes 13100 and 13101, would be included as interim final work RVUs in the CY 2013 PFS final rule with comment period, and their values would ultimately be finalized for CY 2014.</P>
          <HD SOURCE="HD3">3. Skin Grafts</HD>
          <GPH DEEP="100" SPAN="3">
            <GID>EP06JN11.022</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 15120 and 15732 as potentially misvalued through the Site-of-Service Anomaly screen. CPT code 15121 was added as part of the family of services for AMA RUC review. In addition, we identified CPT code 15260 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 15732 (Muscle, myocutaneous, or fasciocutaneous flap; head and neck (e.g., temporalis, masseter muscle, sternocleidomastoid, levator scapulae)) the AMA RUC reviewed the survey results from physicians who frequently perform this service and recommended that this service be valued as a service performed predominately in the facility setting, as the survey data indicated that a majority of patients have an overnight stay. We note that it is unclear whether respondents were offered the option to state that the typical patient is in the hospital more than 24 hours, but not admitted as a hospital inpatient. The AMA RUC believes that this service should not be performed in the outpatient setting and that miscoding is the reason the Medicare utilization data reflect outpatient settings as the dominant place of service for this code. The AMA RUC and the surveyed specialties agreed that additional coding education needs to take place.</P>
          <P>The AMA RUC analyzed the survey's estimated physician work and agreed that these data support the median work RVU of 19.83, for this service, which is slightly less than the current value of 19.90. The AMA RUC recommended a work RVU of 19.83 for CPT code 15732.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 15732 and believe that an alternative work RVU of 16.38 is more appropriate for this service. We are also refining the time associated with this code. Although survey respondents and the AMA RUC indicated that patients receiving this service are typically admitted for more than 24 hours, the most recent Medicare PFS claims data show that CPT code 15732 is a code with a Site-of-Service anomaly. Upon review, it is clear that this code is being billed for services furnished to hospital outpatients, and we have no reason to believe that miscoding is the main reason that outpatient settings are the dominant place of service for this code in historical PFS claims data. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the inpatient hospital visit, reduced the discharge day management service to one-half, and adjusted times. These adjustments resulted in a work RVU of 16.38. We understand the AMA RUC's assertion that claims data indicating that this service is performed in an outpatient setting is the result of miscoding but, until the claims data indicate that this service typically is performed in the inpatient setting (greater than 50 percent), we believe it is inappropriate for the service to be valued including inpatient E/M building blocks. Therefore, we are proposing an alternative work RVU of 16.38 for CPT code 15732 for CY 2012, with refinements to the time. We will continue to monitor Site-of-Service utilization for this code and may consider reviewing the work RVU for this code again in the future if utilization patterns change. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">4. Destruction of Skin Lesions</HD>
          <GPH DEEP="286" SPAN="3">
            <PRTPAGE P="32436"/>
            <GID>EP06JN11.023</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 17271, 17272 and 17280 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen. The dominant specialty for this family—dermatology—identified several other codes in the family to be reviewed concurrently with these services and submitted to the AMA RUC recommendations for CPT codes 17260 through 17286. The AMA RUC determined that, with the exception of one CPT code 17284, the survey data validated the current values of the destruction of skin lesion services. We agreed with this assessment, with a few refinements to physician time.</P>
          <P>For CPT code 17270 (Destruction, malignant lesion (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), scalp, neck, hands, feet, genitalia; lesion diameter 0.5 cm or less), the AMA RUC reviewed the survey results from physicians who frequently perform this service. The AMA RUC noted that the specialty did not provide compelling evidence to change the current value of the service; therefore, the AMA RUC agreed that the survey data support the current value of this service. The AMA RUC recommended a work RVU of 1.37 for CPT code 17270.</P>
          <P>As stated above, we agree with the AMA RUC-recommended work RVU for CPT code 17270 and are proposing a work RVU of 1.37 for CY 2012, with a refinement to the physician time. After clinical review, we believe that an intra-service time of 16 minutes, the survey median, accurately reflects the time required to conduct the intra-service work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 17271 (Destruction, malignant lesion (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), scalp, neck, hands, feet, genitalia; lesion diameter 0.6 to 1.0 cm) the AMA RUC reviewed the survey results from physicians who frequently perform this service. The AMA RUC noted that the specialty did not provide compelling evidence to change the current value of the service; therefore, the AMA RUC agreed that the survey data support the current value of this service. The AMA RUC recommended a work RVU of 1.54 for CPT code 17271.</P>
          <P>As previously stated, we agree with the AMA RUC-recommended work RVU for CPT code 17271 and are proposing a work RVU of 1.54 for CY 2012, with a refinement to the physician time. After clinical review, we believe that 18 minutes, the survey median, accurately reflects the time required to conduct the intra-service work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 17274 (Destruction, malignant lesion (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), scalp, neck, hands, feet, genitalia; lesion diameter 3.1 to 4.0 cm), the AMA RUC reviewed the survey results from physicians who frequently perform this service. The AMA RUC noted that the specialty did not provide compelling evidence to change the current value of the service; therefore, the AMA RUC agreed that the survey data support the current value of this service. The AMA RUC recommended a work RVU of 2.64 for CPT code 17274.</P>
          <P>As stated above, we agree with the AMA RUC-recommended work RVU for CPT code 17274 and are proposing a work RVU of 2.64 for CY 2012, with a refinement to the physician time. After clinical review, we believe that 33 minutes, the survey median, accurately reflects the time required to conduct the intra-service work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">5. Partial Mastectomy</HD>
          <GPH DEEP="060" SPAN="3">
            <PRTPAGE P="32437"/>
            <GID>EP06JN11.024</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT code 19302 as potentially misvalued through the Site-of-Service Anomaly screen.</P>
          <P>For CPT code 19302 (Mastectomy, partial (e.g., lumpectomy, tylectomy, quadrantectomy, segmentectomy); with axillary lymphadenectomy), the AMA RUC reviewed the survey results and determined that the current work relative value for CPT code 19302 appropriately places this service relative to other similar services, specifically CPT code 38745 (Axillary lymphadenectomy; complete) (work RVU = 13.87) which has similar work intensity and time. The AMA RUC recommended a work RVU of 13.99 for CPT code 19302.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 19302 and believe that a work RVU of 13.87 is more appropriate for this service. After clinical review, we agree with the AMA RUC that CPT code 19302 is similar in work intensity and time to CPT code 38745 (Axillary lymphadenectomy; complete) (work RVU = 13.87), which overlaps significantly with CPT code 19302, and as such, we believe these two procedures should have the same work RVU. Therefore, we are proposing an alternative work RVU of 13.87 for CPT code 19302 for CY 2012.</P>
          <HD SOURCE="HD3">6. Percutaneous Vertebroplasty/Kyphoplasty</HD>
          <GPH DEEP="127" SPAN="3">
            <GID>EP06jn11.025</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 22521 as potentially misvalued through the Site-of-Service Anomaly screen. CPT codes 22520, 22522, 22523, 22524 and 22525 were added as part of the family of services for AMA RUC review.</P>
          <P>CPT codes: 22521 (Percutaneous vertebroplasty, 1 vertebral body, unilateral or bilateral injection; lumbar); 22523 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (eg, kyphoplasty); thoracic); and 22524 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (eg, kyphoplasty); lumbar) currently include one full discharge management day, a CPT code building block usually only appropriate for codes that are typically performed in the inpatient setting. As these CPT codes are typically performed in the outpatient setting, the AMA RUC recommended, and we agree, that the discharge management day should be reduced by half. After reviewing the recent history of valuing these codes, the AMA RUC asserted that it believes that an inadvertent clerical error led to these codes showing one full discharge management day in the documentation of their E/M blocks, rather than a half day, and that these codes are actually currently valued using only half a day block. As such, the AMA RUC concluded that the current work RVU for these codes should not be reduced to reflect the removal of the half discharge day. The AMA RUC recommended maintaining the current work RVU for the 6 CPT codes reviewed in this family.</P>
          <P>After reviewing the documentation the AMA RUC provided and CMS records from when the codes were last valued, we do not find compelling evidence that previously these codes were valued to include only a half discharge management day. To the contrary, it appears as though the codes were previously surveyed with one full discharge management day. According to our established policy, we believe it would be appropriate to reduce the work RVU for these codes by the value of the half discharge management day and, therefore, we are removing 0.64 of a work RVU from each code. Therefore, we are proposing an alternative work RVU of 8.01 for CPT code 22521, 8.62 for CPT code 22523, and 8.22 for CPT code 22524 for CY 2012.</P>
          <HD SOURCE="HD3">7. Closed Treatment of Distal Radial Fracture</HD>
          <GPH DEEP="074" SPAN="3">
            <PRTPAGE P="32438"/>
            <GID>EP06jn11.026</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 25600 and 25605 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 25600 (Closed treatment of distal radial fracture (eg, Colles or Smith type) or epiphyseal separation, includes closed treatment of fracture of ulnar styloid, when performed; without manipulation), the AMA RUC reviewed the survey results from physicians who frequently perform this service. The AMA RUC reviewed the number of post-operative visits recommended by the specialties and agreed that they were reflective of the service. The AMA RUC believes that the survey data support the current value of this service, and recommended a work RVU of 2.78 for CPT code 25600.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 25600 and believe that a work RVU of 2.64 is more appropriate for this service. We agree with the AMA RUC that CPT code 25600 requires more work than key reference CPT code 26600, and find that CPT code 27767 (Closed treatment of posterior malleolus fracture; without manipulation) (work RVU = 2.64) is similar in complexity and intensity to CPT code 25600. Therefore, we are proposing an alternative work RVU of 2.64 for CPT code 25600 for CY 2012.</P>
          <P>In addition to the work RVU adjustment for CPT code 25600, we are refining the time associated with this code. This service typically is performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier, to account for this overlap, we reduced the pre-service evaluation and post service time by one-third. We believe that 5 minutes pre-service evaluation time and 7 minutes post-service time accurately reflect the time required to conduct the work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>

          <P>For CPT code 25605 (Closed treatment of distal radial fracture (<E T="03">e.g.,</E>Colles or Smith type) or epiphyseal separation, includes closed treatment of fracture of ulnar styloid, when performed; with manipulation), the AMA RUC reviewed the survey results from physicians who frequently perform this service. The AMA RUC reviewed the number of post-operative visits recommended by the specialties and determined that they are reflective of the service. Based on comparisons to similar codes, the AMA RUC determined that a work RVU of 6.50, the survey's 25th percentile, accurately reflects the work required to perform this service. The AMA RUC recommended a work RVU of 6.50 for CPT code 25605.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 25605 and believe that the survey low value of a work RVU of 6.00 is more appropriate for this service. We find CPT code 28113 (Ostectomy, complete excision; fifth metatarsal head) (work RVU = 6.11) to be similar in intensity and complexity to CPT code 25605, though CPT code 28113 includes higher intensity office visits than CPT code 25605. Therefore, we believe the survey low correctly reflects relativity across these services, and are proposing an alternative work RVU of 6.00 for CPT code 25605 for CY 2012.</P>
          <P>In addition to the work RVU adjustment for CPT code 25605, we are refining the time associated with this code. Recent Medicare PFS claims data show that this service is typically performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. In its time recommendations to us, the AMA RUC accounted for duplicate E/M work associated with the pre-service period, but not the post-service period. To account for this post-service overlap, we reduced the post-service time by one-third, a methodology described in detail in section II.A. of this proposed notice. We believe that 13 minutes post-service time accurately reflect the time required to conduct the work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">8. Orthopaedic Surgery—Thigh/Knee</HD>
          <GPH DEEP="74" SPAN="3">
            <GID>EP06JN11.027</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 27385 and 27530 as potentially misvalued through the Site-of-Service Anomaly screen.</P>
          <P>For CPT code 27385 (Suture of quadriceps or hamstring muscle rupture; primary), the AMA RUC reviewed the survey results from physicians who frequently perform this service and determined that there was no compelling evidence that the work required to perform this service has changed. The AMA RUC recommended that this service be valued as a service performed predominately in the facility setting, as the survey data indicated that half of patients have an overnight stay. The AMA RUC recommended a work RVU of 8.11 for CPT code 27385.</P>

          <P>We disagree with the AMA RUC-recommended work RVU of 8.11 for CPT code 27385 and believe that a work RVU of 6.93 is more appropriate for this service. We are also refining the time<PRTPAGE P="32439"/>associated with this code. We note the data survey indicate that of those respondents who stated that they typically perform the procedure in the hospital, 19 percent (6 out of 32) stated that the patient is “discharged the same day,” 31 percent (10 out of 32) stated the patient is “kept overnight (less than 24 hours),” and 50 percent (16 out of 32) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent Medicare PFS claims data, CPT code 27385 is a code with a Site-of-Service anomaly since more than 50 percent of the Medicare utilization is not inpatient. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the hospital visit, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 6.93 with refinements to the time for CPT code 27385 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 27530 (Closed treatment of tibial fracture, proximal (plateau); without manipulation), the AMA RUC reviewed the survey responses from 33 (of 200 surveyed) physicians. Based on comparisons to reference codes, the AMA RUC recommended a work RVU of 2.81 for CPT code 27530.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 27530 and believe that a work RVU of 2.65 is more appropriate for this service. We are also refining the time associated with this code. Recent Medicare PFS claims data show that this service is typically performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. We believe that 5 minutes pre-service evaluation time and 7 minutes post-service time accurately reflect the time required to conduct the work associated with this service. We also removed the 2 minutes of pre-service positioning time, as it does not appear from the vignette that positioning is required for a non-manipulated extremity.</P>
          <P>In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU. For CPT code 27530, we removed a total of 7 minutes from the AMA RUC-recommended pre- and post-service time, which amounts to the removal of 0.16 of a work RVU. Therefore, we are proposing an alternative work RVU of 2.65 with refinement in time for CPT code 27530 for CY 2012. A complete list of CMS time refinements can be found in Table 6. Additionally, we recommend that the AMA RUC examine all of the non-manipulation fracture codes to determine if positioning time was incorporated into the work RVU for the codes and, if so, whether the need for positioning time was documented.</P>
          <HD SOURCE="HD3">9. Treatment of Ankle Fracture</HD>
          <GPH DEEP="61" SPAN="3">
            <GID>EP06JN11.028</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT code 27792 (Open treatment of distal fibular fracture (lateral malleolus), includes internal fixation, when performed) as potentially misvalued through the Site-of-Service Anomaly screen. For CPT code 27792, the AMA RUC used magnitude estimation and recommended that the current value of this service, 9.71 RVUs, be maintained, and replaced the current inpatient hospital E/M visit block with a subsequent observation care service while maintaining a full discharge day management service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 9.71 for CPT code 27792. The AMA RUC indicated in its summary of recommendations that the survey data show 100 percent (53 out of 53) of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 42 percent (22 out of 53) stated that the patient is “discharged the same day,” 44 percent (23 out of 53) stated the patient is “kept overnight (less than 24 hours),” and 13 percent (7 out of 53) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent Medicare PFS claims data, CPT code 27792 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 8.75 with refinements to the time for CPT code 27792 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">10. Orthopaedic Surgery/Podiatry</HD>
          <GPH DEEP="153" SPAN="3">
            <PRTPAGE P="32440"/>
            <GID>EP06JN11.029</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 28002, 28120, 28122, 28715, 28820, and 28825 as potentially misvalued through the Site-of-Service Anomaly screen. CPT code 28003 was added as part of the family of services for AMA RUC review. CMS also identified CPT code 28285 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 28002 (Incision and drainage below fascia, with or without tendon sheath involvement, foot; single bursal space), the AMA RUC reviewed the survey responses and determined that CPT code 28002 should be decreased to the survey 25th percentile work RVU. The AMA RUC recommended a work RVU of 5.34 for CPT code 28002.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 28002 and believe that the survey low value of a work RVU of 4.00 is more appropriate for this service. We find CPT code 28002 to be closer to the complexity and intensity of CPT code 58353 (Endometrial ablation, thermal, without hysteroscopic guidance) (work RVU = 3.60) which has similar times and lower-level visits to CPT code 28002. We believe that the survey low value accurately reflects the work associated with this service and are proposing an alternative work RVU of 4.00 for CPT code 28002 for CY 2012.</P>

          <P>For CPT code 28120 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (<E T="03">e.g.,</E>osteomyelitis or bossing); talus or calcaneus), the AMA RUC used magnitude estimation, recommended that the current work RVU of 8.27 for this service be maintained, and replaced the current inpatient hospital E/M visit block with a subsequent observation care service while maintaining a full discharge day management service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 8.27 for CPT code 28120. The AMA RUC indicated in its summary of recommendations that the survey data show 87 percent (45 out of 52) of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 16 percent (7 out of 45) stated that the patient is “discharged the same day,” 18 percent (8 out of 45) stated the patient is “kept overnight (less than 24 hours),” and 67 percent (30 out of 45) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent Medicare PFS claims data, CPT code 28120 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 7.31 with refinements to the time for CPT code 28120 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>

          <P>For CPT code 28122 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (<E T="03">e.g.,</E>osteomyelitis or bossing); tarsal or metatarsal bone, except talus or calcaneus), the AMA RUC used magnitude estimation, recommended that the current work RVU of 7.56 for this service should be maintained for CY 2012, and replaced the current inpatient hospital E/M visit block with a subsequent observation care service while maintaining a full discharge day management service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 7.56 for CPT code 28122. The AMA RUC indicated in its summary of recommendations that the survey data show 83 percent (43 out of 52) of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 12 percent (5 out of 43) stated that the patient is “discharged the same day,” 30 percent (13 out of 43) stated the patient is “kept overnight (less than 24 hours),” and 58 percent (23 out of 43) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent Medicare PFS claims data, CPT code 28122 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 6.76 with refinements to the time for CPT code 28122 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 28285 (Correction, hammertoe (<E T="03">e.g.,</E>interphalangeal fusion, partial or total phalangectomy)), the AMA RUC reviewed the survey responses and agreed that the appropriate work RVU for CPT code 28285 is a work RVU of 5.62, crosswalked from CPT code 28675. The AMA RUC recommended a work RVU of 5.62 for CPT code 28285.</P>

          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 28285 and believe that a work RVU of 4.76, the current work RVU, is more appropriate for this service. The majority of survey respondents indicated that the work of performing this service has not changed in the past 5 years (67 percent), and that there has been no change in complexity among<PRTPAGE P="32441"/>the patients requiring this service (81 percent). We believe that the current work RVU accurately reflects the work associated with this service. Therefore, we are proposing an alternative work RVU of 4.76 for CPT code 28675 for CY 2012.</P>
          <P>For CPT code 28715 (Arthrodesis; triple), the AMA RUC reviewed the survey responses from 30 (of 150 surveyed) physicians for CPT code 28715 and determined that the current work RVU of 14.60 maintains the correct relativity among similar services. The AMA RUC recommended that this service be valued as a service performed predominately in the facility setting. The AMA RUC indicated that since the typical patient is kept overnight, the AMA RUC believes that one inpatient hospital visit as well as one discharge day management service should be maintained in the post-operative visits for this service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 28715 and believe that a work RVU of 13.42 is more appropriate for this service. While the survey data show 93 percent (28 out of 30) of survey respondents stated they perform the procedure “in the hospital,” of those respondents who stated that they typically perform the procedure in the hospital, 7 percent (2 out of 28) stated that the patient is “discharged the same day,” 32 percent (9 out of 28) stated the patient is “kept overnight (less than 24 hours),” and 61 percent (17 out of 28) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent Medicare PFS claims data, CPT code 28715 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the inpatient hospital visit, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 13.42 with refinements to the time for CPT code 28715 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 28820 (Amputation, toe; metatarsophalangeal joint), the AMA RUC reviewed the survey responses and determined that the survey median work RVU of 7.00 appropriately reflects the physician work required to perform this service and maintains relativity among similar services. Therefore, the AMA RUC recommended a work RVU of 7.00 for CPT code 28820. In its recommendation to us for CPT code 28820, the AMA RUC included one post-operative hospital visit and one full discharge management day.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 28820 and believe that a work RVU of 5.82 is more appropriate for this service. The survey data for this code show that 87 percent of respondents indicated that they perform this procedure in the hospital, but without a distinction between the patient's status as a hospital inpatient or outpatient. Recent Medicare PFS claims data indicate that this service is typically (greater than 50 percent) performed in the outpatient setting. As we discussed in section II.A. of this proposed notice, for codes with Site-of-Service anomalies where the service is typically performed in the outpatient setting but valued with inpatient inputs, our policy is to remove any post-procedure inpatient visits remaining in the values for the codes, and adjust the physician times and work RVU accordingly. Therefore, in accordance with this policy, we reduced the discharge management day to half a day, eliminated the post-operative hospital visit, and adjusted the time and work RVU accordingly. As a result, we are proposing an alternative work RVU of 5.82 with refinements to the time for CPT code 28820 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 28825 (Amputation, toe; interphalangeal joint), the AMA RUC used magnitude estimation and ultimately recommended maintaining the current work RVU of 6.01, while also maintaining a full discharge day management service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 6.01 for CPT code 28825. The AMA RUC indicated in its summary of recommendations that the survey data show 84 percent (37 out of 44) of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 36 percent (13 out of 37) stated that the patient is “discharged the same day,” 11 percent (4 out of 37) stated the patient is “kept overnight (less than 24 hours),” and 52 percent (19 out of 37) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent Medicare PFS claims data, CPT code 28825 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 5.37 with refinements to the time for CPT code 28825 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">11. Application of Cast and Strapping</HD>
          <GPH DEEP="113" SPAN="3">
            <GID>EP06JN11.030</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 29125, 29405 and 29515 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen. CPT codes 29126 and 29425 were added as part of the family of services for AMA RUC review.</P>

          <P>For CPT code 29125 (Application of short arm splint (forearm to hand); static), the AMA RUC reviewed the survey results and determined that these<PRTPAGE P="32442"/>data support maintaining the current work RVU of 0.59 for this service. The AMA RUC recommended a work RVU of 0.59 for CPT code 29125. In its recommendation to us, the AMA RUC also noted that there is typically an E/M service furnished on the same day as this service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 29125 and believe that a work RVU of 0.50 is more appropriate for this service. We are also refining the time associated with this code. Recent Medicare PFS claims data affirm that this service is typically performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. We believe that 5 minutes pre-service evaluation time and 3 minutes post-service time accurately reflect the time required to conduct the work associated with this service as described by the CPT code-associated specialties to the AMA RUC.</P>
          <P>In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU. For CPT code 29125, we removed a total of 4 minutes from the AMA RUC-recommended pre- and post-service time, which amounts to the removal of 0.09 of a work RVU. Therefore, we are proposing an alternative work RVU of 0.50 with refinement in time for CPT code 29125 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 29126 (Application of short arm splint (forearm to hand); dynamic), the AMA RUC reviewed the survey results and determined that the median work RVU overestimates the work value for this service and that there is no compelling evidence that the physician work has recently changed. Therefore, the AMA RUC recommended maintaining the current work RVU of 0.77 for CPT code 29126. In its recommendation to us, the AMA RUC noted that there is typically an E/M service furnished on the same day as this service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 29126 and believe that a work RVU of 0.68 is more appropriate for this service. We are also refining the time associated with this code. Recent Medicare PFS claims data affirm that this service is typically performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. We believe that 5 minutes pre-service evaluation time and 3 minutes post-service time accurately reflect the time required to conduct the work associated with this service as described by the CPT code-associated specialties to the AMA RUC.</P>
          <P>In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU. For CPT code 29126, we removed a total of 4 minutes from the AMA RUC-recommended pre- and post-service time, which amounts to the removal of 0.09 of a work RVU. Therefore, we are proposing an alternative work RVU of 0.68 with refinement in time for CPT code 29126 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 29515 (Application of short leg splint (calf to foot)), the AMA RUC reviewed the survey results and determined that these data support maintaining the current work RVU of 0.73 for this service. The AMA RUC recommended a work RVU of 0.73 for CPT code 29515. In its recommendation to us, the AMA RUC noted that there is typically an E/M service furnished on the same day as this service.</P>
          <P>We agree with the AMA RUC-recommended work RVU of 0.73 for CPT code 29515, with a refinement to time. Recent Medicare PFS claims data affirm that this service is typically performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. We believe that 5 minutes pre-service evaluation time and 3 minutes post-service time accurately reflect the time required to conduct the work associated with this service as described by the CPT code-associated specialties to the AMA RUC. Despite this reduction in time, after clinical review we believe that the AMA RUC-recommended work RVU of 0.73 accurately reflects the work associated with this service and maintains appropriate relativity with similar services. Therefore, we are proposing a work RVU of 0.73 for CY 2012, with a refinement to the time.</P>
          <HD SOURCE="HD3">12. Cardiothoracic Surgery</HD>
          <GPH DEEP="506" SPAN="3">
            <PRTPAGE P="32443"/>
            <GID>EP06JN11.031</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT code 33411 (Replacement, aortic valve; with aortic annulus enlargement, noncoronary sinus) as potentially misvalued through the Site-of-Service Anomaly screen. We included a number of services that were also identified by the Society of Thoracic Surgeons (STS) in their public comments regarding candidate services for the Fourth Five-Year Review, including ventricular assist device (VAD) removal codes, VAD insertion and replacement codes, lung transplant codes, pulmonary artery embolectomy codes, descending thoracic aorta repair codes, congenital cardiac codes and general thoracic surgery CPT code 43415 (Suture of esophageal wound or injury; transthoracic or transabdominal approach). In its review of these cardiothoracic surgery codes, the AMA RUC recommended increasing the work RVUs for most of the codes (often substantially), while recommending that many of the service times be reduced. We also note that many of these codes have had the same work value since 1993, potentially historically supporting the longstanding appropriateness of the value from the perspective of interested specialties. While we discuss the proposed values for each revised code below, we note that for most of the codes in this family (but not all) we agreed with the AMA RUC that the work RVU should be increased, but believe that the survey 25th percentile work RVU reflected a clinically more appropriate increase than the work RVU recommended by the AMA RUC.</P>

          <P>Additionally, the AMA RUC recommended global period changes for several codes in the category of cardiothoracic surgery. For CY 2012, we<PRTPAGE P="32444"/>agree with the AMA RUC-recommended global period changes and work RVUs and are proposing the following: For CPT code 33977 (Removal of ventricular assist device; extracorporeal, single ventricle), a proposed work RVU of 20.86 and global period change from 090 to XXX (a global period of XXX means the concept does not apply); for CPT code 33978 (Removal of ventricular assist device; extracorporeal, biventricular), a proposed work RVU of 25 and global period change from 090 to XXX; for CPT code 36200 (Introduction of catheter, aorta), a proposed work RVU of 3.02 and global period change from XXX to 000; for CPT code 36246 (Selective catheter placement, arterial system; initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family), a proposed work RVU of 5.27 and a global period change from XXX to 000; and for CPT code 36821 (Arteriovenous anastomosis, open; direct, any site (eg, cimino type) (separate procedure)), a proposed work RVU of 12.11 and a global period change from XXX to 000.</P>
          <P>For CPT code 32851 (Lung transplant, single; without cardiopulmonary bypass), the AMA RUC reviewed the survey responses and determined that the survey 25th percentile work RVU of 63.00 appropriately accounts for the physician work required to perform this service.</P>

          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 32851 and believe that a work RVU of 59.64 is more appropriate for this service. Comparing CPT code 33255 (Operative tissue ablation and reconstruction of atria, extensive (eg, maze procedure); without cardiopulmonary bypass) (work RVU = 29.04) with CPT code 33256 (Operative tissue ablation and reconstruction of atria, extensive (<E T="03">e.g.,</E>maze procedure); with cardiopulmonary bypass) (work RVU = 34.90), there is a difference in work RVU of 5.86. This difference in work RVUs reflects the additional time and physician work performed while the patient is on cardiopulmonary bypass. We believe that this is the appropriate interval in physician work distinguishing CPT code 32852 (Lung transplant, single; with cardiopulmonary bypass), from CPT code 32851 (Lung transplant, single; without cardiopulmonary bypass). As we are proposing a work RVU of 65.05 for CPT code 32852 (see below), we believe a work RVU of 59.64 accurately reflects the work associated with CPT code 32851 and maintains appropriate relativity among similar services. Therefore, we are proposing an alternative work RVU of 59.64 for CPT code 32851 for CY 2012.</P>
          <P>For CPT code 32852 (Lung transplant, single; with cardiopulmonary bypass), the AMA RUC reviewed the survey responses and determined that the survey 25th percentile work RVU was too low and the median work RVU was too high. Therefore, the AMA RUC recommended a work RVU of 74.37 for CPT code 32582.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 32582 and believe that the survey 25th percentile value of a work RVU of 65.50 is more appropriate for this service. Therefore, we are proposing an alternative work RVU of 65.50 for CPT code 32582 for CY 2012.</P>
          <P>For CPT code 32853 (Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary bypass), the AMA RUC reviewed the survey responses and determined that the survey median work RVU of 90.00 appropriately accounts for the physician work required to perform this service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 32853 and believe that the survey 25th percentile value of 84.48 is more appropriate for this service as a reflection of the time and intensity of the service in relation to other major surgical procedures. Therefore, we are proposing an alternative work RVU of 84.48 for CPT code 32853 for CY 2012.</P>
          <P>For CPT code 32854 (Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass), the AMA RUC reviewed the survey responses and determined that the survey median work RVU of 95.00 appropriately accounts for the physician work required to perform this service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 32854 and believe that the survey 25th percentile value of 90.00 is more appropriate for this service. A work RVU of 90.00 maintains the relativity between CPT code 32851 (Lung transplant, single; without cardiopulmonary bypass) and CPT code 32854, which describes a double lung transplant. We believe this work RVU reflects the increased intensity in total service for CPT code 32584 when compared to CPT code 32851. Therefore, we are proposing an alternative work RVU of 90.00 for CPT code 32854 for CY 2012.</P>
          <P>For CPT code 33030 (Pericardiectomy, subtotal or complete; without cardiopulmonary bypass), the AMA RUC reviewed the survey responses and determined that the survey median work RVU of 39.50 for CPT code 33030 appropriately accounts for the work required to perform this service.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33030 and believe that the survey 25th percentile value of 36.00 is more appropriate for this service. Therefore, we are proposing an alternative work RVU of 36.00 for CPT code 33030 for CY 2012.</P>
          <P>For CPT code 33120 (Excision of intracardiac tumor, resection with cardiopulmonary bypass), the AMA RUC reviewed the survey responses and determined that the 25th percentile work RVU for CPT code 33120 appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 42.88 for CPT code 33120.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33120 and believe that a work RVU of 38.45 is more appropriate for this service. We compared CPT code 33120 with CPT code 33677 (Closure of multiple ventricular septal defects; with removal of pulmonary artery band, with or without gusset) (work RVU = 38.45) and found the codes to be the similar in complexity and intensity. We believe that a work RVU of 38.45 accurately reflects the work associated with CPT code 33677 and properly maintains the relativity of similar service. Therefore, we are proposing an alternative work RVU of 38.45 for CPT code 33120 for CY 2012.</P>
          <P>For CPT code 33412 (Replacement, aortic valve; with transventricular aortic annulus enlargement (Konno procedure)), the AMA RUC reviewed the survey responses and determined that the survey median work RVU for CPT code 33412 appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 60.00 for CPT code 33412.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33412 and believe that the survey 25th percentile value of 59.00 is more appropriate for this service. Therefore, we are proposing an alternative work RVU of 59.00 for CPT code 33412 for CY 2012.</P>
          <P>For CPT code 33468 (Tricuspid valve repositioning and plication for Ebstein anomaly), the AMA RUC reviewed the survey responses and determined that the survey median work RVU for CPT code 33468 appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 50.00 for CPT code 33468.</P>

          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33468 and believe that the survey 25th percentile value of 45.13 is more<PRTPAGE P="32445"/>appropriate for this service. Therefore, we are proposing an alternative work RVU of 45.13 for CPT code 33468 for CY 2012.</P>
          <P>For CPT code 33645 (Direct or patch closure, sinus venosus, with or without anomalous pulmonary venous drainage), the AMA RUC reviewed survey responses and determined that the survey median work RVU for CPT code 33645 appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 33.00 for CPT code 33645.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33645 and believe that the survey 25th percentile value of 31.30 appropriately captures the total work for the service. Therefore, we are proposing an alternative work RVU of 31.30 for CPT code 33645 for CY 2012.</P>
          <P>For CPT code 33647 (Repair of atrial septal defect and ventricular septal defect, with direct or patch closure), the AMA RUC reviewed survey responses and determined that the survey median work RVU for CPT code 33467 appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 35.00 for CPT code 33647.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33647 and believe that the survey 25th percentile value of 33.00 is more appropriate for this service. Therefore, we are proposing an alternative work RVU of 33.00 for CPT code 33647 for CY 2012.</P>
          <P>For CPT code 33692 (Complete repair tetralogy of Fallot without pulmonary atresia), the AMA RUC reviewed survey responses, determined that the survey median work RVU for CPT code 33692 appropriately accounts for the work, and recommended a median work RVU of 38.75 for CPT code 33692.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33692 and believe that the survey 25th percentile value of 36.15 is more appropriate for this service. Therefore, we are proposing an alternative work RVU of 36.15 for CPT code 33692 for CY 2012.</P>
          <P>For CPT code 33710 (Repair sinus of Valsalva fistula, with cardiopulmonary bypass; with repair of ventricular septal defect), the AMA RUC reviewed survey response, determined that the survey median work RVU for CPT code 33710 appropriately accounts for the work required to perform this service, and recommended a work RVU of 43.00 for CPT code 33710.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33710 and believe that the survey 25th percentile value of 37.50 is more appropriate for this service. We believe the physician time and intensity for CPT code 33710 reflects the appropriate incremental adjustment when compared to the reference service, CPT code 33405. Therefore, we are proposing an alternative work RVU of 37.50 for CPT code 33710 for CY 2012.</P>
          <P>For CPT code 33875 (Descending thoracic aorta graft, with or without bypass), the AMA RUC reviewed survey responses and determined that the 25th percentile work RVU for code 33875 appropriately accounts for the work required to perform this service. The AMA RUC recommended a work RVU of 56.83 for CPT code 33875.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33875 and believe that a work RVU of 50.72 is more appropriate for this service. We compared CPT code 33875 with CPT code 33465 (Replacement, tricuspid valve, with cardiopulmonary bypass) (work RVU = 50.72) and believe that CPT code 33875 is similar to CPT code 33465, with similar inpatient and outpatient work. We believe this work RVU corresponds better to the value of the service than the survey 25th percentile work RVU. Therefore, we are proposing an alternative work RVU of 50.72 for CPT code 33875 for CY 2012.</P>
          <P>For CPT code 33910 (Pulmonary artery embolectomy; with cardiopulmonary bypass), the AMA RUC reviewed survey responses. After reviewing the service, the AMA RUC determined that it met the compelling evidence guidelines. The AMA RUC recommended a work RVU of 52.33 for CPT code 33910.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33910 and believe that a work RVU of 48.21 is more appropriate for this service. We compared CPT code 33910 with CPT code 33542 (Myocardial resection (eg, ventricular aneurysmectomy)) (work RVU = 48.21), and we recognize that CPT code 33542 is not an emergency service. Nevertheless, this procedure requires cardiopulmonary bypass and has physician time and visits that are similar to CPT code 33910 and that are consistently necessary for the care required for the patient. We believe that a work RVU of 48.21 accurately reflects the work associated with CPT code 33910 and properly maintains the relativity for a similar service. Therefore, we are proposing an alternative work RVU of 48.21 for CPT code 33910 for CY 2012.</P>
          <P>For CPT code 33935 (Heart-lung transplant with recipient cardiectomy-pneumonectomy), the AMA RUC reviewed survey responses, determined that the survey median work RVU appropriately accounts for the physician work required to perform this service, and recommended a work RVU of 100.00 for CPT code 33935.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 33935 and believe that the survey 25th percentile value of 91.78 is more appropriate for this service. We believe this service is more intense and complex than CPT code 33945 and that the survey 25th percentile work RVU accurately reflects the increased intensity and complexity when compared to the reference CPT code 33945. Therefore, we are proposing an alternative work RVU of 91.78 for CPT code 33935 for CY 2012.</P>
          <P>For CPT code 33980 (Removal of ventricular assist device, implantable intracorporeal, single ventricle), the AMA RUC reviewed the survey results and recommended the survey median work RVU of 40.00. Additionally the AMA RUC recommended a global period change from 090 to XXX. We agree with the AMA RUC-recommended global period change from 90 to XXX. However, we disagree with the AMA RUC-recommended work RVU for CPT code 33980 and are proposing for CY 2012 an alternative work RVU of 33.50, which is the survey 25th percentile work RVU. We believe the work RVU of 33.50 is more appropriate, given the significant reduction in physician times and decrease in the number and level of post-operative visits that the AMA RUC included in the value of CPT code 33980.</P>
          <P>For CPT code 36247 (Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family), the AMA RUC considered the survey results and recommended the survey median work RVU of 7.00 for this service. Additionally, the AMA RUC recommended a global period change from 090 to XXX. We agree with the AMA RUC-recommended global period change from 90 to XXX. However, we disagree with the AMA RUC-recommended work RVU of 7.00 for CPT code 36247. We believe maintaining the current work RVU is more appropriate given the change to the global period. Accordingly we are proposing a work RVU of 6.29 for CPT code 36247 for CY 2012.</P>

          <P>For CPT code 36825 (Creation of arteriovenous fistula by other than direct arteriovenous anastomosis (separate procedure); autogenous graft), the AMA RUC considered the survey data and ultimately recommended that<PRTPAGE P="32446"/>the current work RVU of this service, 15.13, be maintained.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 15.13 for CPT code 36825. As indicated by the most recent Medicare PFS claims data, CPT code 28122 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 14.17 with refinements to the time for CPT code 36825 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">13. Vascular Surgery</HD>
          <GPH DEEP="208" SPAN="3">
            <GID>EP06JN11.032</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT code 36819 as potentially misvalued through the Site-of-Service Anomaly screen, and we identified CPT code 36600 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen. The Society for Vascular Surgery submitted additional CPT codes to be included in the Fourth Five-Year Review, including CPT codes 35188, 35612, 35800, 35840, 35860, 37140, 37145, 37160, 37180, and 38181.</P>
          <P>The AMA RUC noted that it believed there is compelling evidence to change the work values for CPT codes 35188, 35612, 35800, 35840, and 35860, since vascular surgery is one of the predominant providers of these services and had not participated in the original Harvard studies. In addition, the AMA RUC believes errors occurred in extrapolation of visits during the Harvard study, and apparent rank order anomalies may emerge when comparing these services to other vascular procedures.</P>
          <P>For CPT code 35188 (Repair, acquired or traumatic arteriovenous fistula; head and neck), the AMA RUC reviewed the survey results from 25 (out of a sample size of 400) physicians and recommended the survey median work RVU of 18.50 for CPT code 35188.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 35188 and are proposing for CY 2012 an alternative work RVU of 18.00, which is the survey 25th percentile work RVU. We believe the work RVU of 18.00 is more appropriate, given the decrease in the number and level of post-operative visits that the AMA RUC included in the value of CPT code 35188.</P>
          <P>For CPT code 35612 (Bypass graft, with other than vein; subclavian-subclavian), the AMA RUC reviewed the survey results from 25 (out of a sample size of 400) physicians and recommended a work RVU of 22.00 for CPT code 35612.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 35612 and are proposing for CY 2012 an alternative work RVU of 20.35, which is the survey 25th percentile work RVU. We believe the work RVU of 20.35 is more appropriate, given the decrease in the number and level of post-operative visits that the AMA RUC included in the value of CPT code 35612.</P>
          <P>For CPT code 35800 (Exploration for postoperative hemorrhage, thrombosis or infection; neck), the AMA RUC reviewed the survey results from 34 (out of a sample size of 400) physicians. Using magnitude estimation, the AMA RUC recommended that an appropriate work RVU for CPT code 35800 would be between the survey 25th percentile (12.00 RVU) and median (15.00 RVU) work value. Accordingly, the AMA RUC recommended a work RVU of 13.89 for CPT code 35800.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 35800 and are proposing for CY 2012 an alternative work RVU of 12.00, which is the survey 25th percentile work RVU. We believe the work RVU of 12.00 is more appropriate, given that two of the key reference codes to which this service has been compared have identical intra-service time (60 minutes), but significantly lower work RVUs.</P>
          <P>For CPT code 35840 (Exploration for postoperative hemorrhage, thrombosis or infection; abdomen), the AMA RUC reviewed the survey results from 34 (out of a sample size of 400) physicians. Using magnitude estimation, the AMA RUC recommended that an appropriate work RVU for CPT code 35840 would be between the survey 25th percentile (19.25 RVU) and median (22.30 RVU) work value. Accordingly, the AMA RUC recommended a work RVU of 21.19 for CPT code 35840.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 35840 and are proposing for CY 2012 an alternative work RVU of 20.75, which is between the survey 25th percentile and median work RVU. We believe the work RVU of 20.75 is more appropriate given the two reference codes to which this service has been compared.</P>

          <P>For CPT code 35860 (Exploration for postoperative hemorrhage, thrombosis or infection; extremity), the AMA RUC<PRTPAGE P="32447"/>reviewed the survey results from 34 (out of a sample size of 400) physicians. Using magnitude estimation, the AMA RUC recommended that an appropriate work RVU for CPT code 35860 would be between the survey 25th percentile (15.25 RVUs) and median work value (18.00 RVUs). Accordingly, the AMA RUC recommended a work RVU of 16.89 for CPT code 35860.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 35860 and are proposing for CY 2012 an alternative work RVU of 15.25, which is the survey 25th percentile work RVU. We believe this work RVU maintains appropriate relativity within the family of related services for the exploration of postoperative hemorrhage.</P>
          <P>For CPT code 36600 (Arterial puncture, withdrawal of blood for diagnosis), the AMA RUC reviewed the survey results from 38 (out of a sample size of 100) physicians and, based on comparisons to reference codes, recommended a work RVU of 0.32 for CPT code 36600.</P>
          <P>We agree with the AMA RUC's recommended work RVU and are proposing a work RVU of 0.32 for CPT code 36600 for CY 2012. In addition to the work RVU adjustment for CPT code 36600, we are refining the time associated with this code. Recent Medicare PFS claims data show that this service typically is performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. We believe that 3 minutes pre-service evaluation time and 3 minutes post-service time accurately reflect the time required to conduct the work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 36819 (Arteriovenous anastomosis, open; by upper arm basilic vein transposition), which was identified as a code with a Site-of-Service anomaly, the AMA RUC reviewed the survey results from 31 (out of a sample size of 400) physicians. The AMA RUC indicated that it believes this service should be categorized as one being typically performed in an inpatient hospital setting and recommended maintaining the current work RVU of 14.47.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 36819. The AMA RUC indicated in its summary of recommendations that the survey data show 97 percent (30 out of 31) of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 33 percent (10 out of 30) stated that the patient is “discharged the same day,” 53 percent (16 out of 30) stated the patient is “kept overnight (less than 24 hours),” and 13 percent (4 out of 30) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As we discussed in section II.A. of this proposed notice, for codes with Site-of-Service anomalies, our policy is to remove any post-procedure inpatient visits remaining in the values for these codes and adjust physician times accordingly. It is also our policy for codes with Site-of-Service anomalies to consistently include the value of half of a discharge day management service and adjust physician times accordingly. We are thus proposing an alternative work RVU for CY 2012 of 13.29 with refinements in time for CPT code 36819. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">14. Excise Parotid Gland/Lesion</HD>
          <GPH DEEP="75" SPAN="3">
            <GID>EP06JN11.033</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 42415 and 42420 as Site-of-Service anomaly codes.</P>
          <P>For CPT code 42415 (Excision of parotid tumor or parotid gland; lateral lobe, with dissection and preservation of facial nerve), the AMA RUC reviewed the survey data and, based on magnitude estimation, the AMA RUC recommended that the current work RVU of this service, 18.12, be maintained.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 18.12 for CPT code 42415. As indicated by the most recent Medicare PFS claims data, CPT code 42415 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 17.16 with refinements to the time for CPT code 42415 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 42420 (Excision of parotid tumor or parotid gland; total, with dissection and preservation of facial nerve), the AMA RUC reviewed survey results and, based on magnitude estimation, the AMA RUC recommended that the current work RVU of this service, 21.00, be maintained.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 21.00 for CPT code 42420. As indicated by the most recent Medicare PFS claims data, CPT code 42420 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 19.53 with refinements to the time for CPT code 42420 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">15. Endoscopic Cholangiopancreatography</HD>
          <GPH DEEP="56" SPAN="3">
            <PRTPAGE P="32448"/>
            <GID>EP06JN11.034</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT code 43262 as potentially misvalued through the Harvard Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 43262 (Endoscopic retrograde cholangiopancreatography (ERCP); with sphincterotomy/papillotomy), the AMA RUC reviewed the service and believes that the specialty did not provide compelling evidence to change the current value of the service. Therefore, the AMA RUC recommended maintaining the current work RVU of 7.38 for CPT code 43262.</P>
          <P>We are proposing to maintain the current work RVU of 7.38 and the current physician time for CPT code 43262 for CY 2012. However, we are requesting that the AMA RUC undertake a comprehensive review of the entire family of ERCP codes, including the base CPT code 43260, and provide CMS with work RVU recommendations. We note that based on a preliminary review of the intra-service times for these codes, we are concerned the codes in this family are potentially misvalued.</P>
          <HD SOURCE="HD3">16. Sigmoidoscopy</HD>
          <GPH DEEP="56" SPAN="3">
            <GID>EP06JN11.035</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, CMS identified CPT code 45331 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 45331 (Sigmoidoscopy, flexible; with biopsy, single or multiple), the AMA RUC reviewed the survey results and determined that the survey data support the current value of this service. Taking into consideration the 75th percentile of the survey results, the AMA RUC recommended a pre-service time of 15 minutes, intra-service time of 15 minutes, and post-service time of 10 minutes. Accordingly, the AMA RUC recommended a work RVU of 1.15 for CPT code 45331.</P>
          <P>We agree with the AMA RUC's recommended work RVU and are proposing a work RVU of 1.15 for CPT code 45331 for CY 2012. However, while the AMA RUC recommended pre-service times based on the 75th percentile of the survey results, we believe it is more appropriate to accept the median survey physician times. Accordingly, we are refining the times to the following: 5 minutes for pre-evaluation; 5 minutes for pre-service other, 5 minutes for pre- dress, scrub, and wait; 10 minutes intra-service; and 10 minutes immediate post-service. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">17. Laparoscopic Cholecystectomy</HD>
          <GPH DEEP="64" SPAN="3">
            <GID>EP06JN11.036</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, CMS identified CPT code 47563 as potentially misvalued through the Harvard Valued—Utilization &gt; 30,000 screen and Site-of-Service Anomaly screen. The AMA RUC reviewed CPT codes 47564 and 47563.</P>
          <P>For CPT code 47563 (Laparoscopy, surgical; cholecystectomy with cholangiography), the AMA RUC reviewed the survey results and recommended that this service be valued as a service performed predominately in the facility setting, as the survey data indicated that a majority of patients have an overnight stay. Because some respondents stated that the typical patient would be kept at overnight in the hospital, the AMA RUC recommended a full day discharge management service be included in the value of the service. The AMA RUC recommended maintaining the current work RVU of 12.11 for CPT code 47563.</P>

          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 47563. While the survey data show 95 percent (57 out of 60) of survey respondents stated they perform the procedure “in the hospital,” of those respondents who stated that they typically perform the procedure in the hospital, 30 percent (17 out of 57) stated that the patient is “discharged the same day,” 46 percent (26 out of 57) stated the patient is “kept overnight (less than 24 hours),” and 25 percent (14 out of 57) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As we discussed in section II.A. of this proposed notice, for codes with Site-of-Service anomalies, our policy is to remove any post-procedure inpatient visits remaining in the values for these codes and adjust physician times accordingly. It is also our policy for codes with Site-of-Service anomalies to consistently include the value of half of a discharge day management service, adjusting physician times accordingly. We are thus proposing an alternative work RVU of 11.47 with refinements in time for CPT code 47563 for CY 2012.<PRTPAGE P="32449"/>A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 47564 (Laparoscopy, surgical; cholecystectomy with exploration of common duct), the AMA RUC reviewed the survey results and determined that the 25th survey percentile was appropriate for this service. Accordingly, the AMA RUC recommended a work RVU of 20.00 for CPT code 47564.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 47564 and are proposing for CY 2012 an alternative work RVU of 18.00, which is the survey low work RVU. We are accepting the AMA RUC recommended median survey times and believe the work RVU of 18.00 for CPT code 35860 is more appropriate given the significant reduction in recommended physician times in comparison to the current times.</P>
          <HD SOURCE="HD3">18. Hernia Repair</HD>
          <GPH DEEP="88" SPAN="3">
            <GID>EP06JN11.037</GID>
          </GPH>
          <P>In 2007, the AMA RUC's Relativity Assessment Workgroup identified CPT codes 49507, 49521 and 49587 as potentially misvalued through the Site-of-Service Anomaly screen. The American College of Surgeons (ACS) surveyed these codes, and the AMA RUC issued recommended work values for these codes to CMS for CY 2010. In the CY 2011 PFS final rule with comment period (75 FR 73221), we reiterated that in the CY 2010 PFS final rule with comment period (74 FR 61776 through 61778) we indicated that although we would accept the AMA RUC valuations for these Site-of-Service anomaly codes on an interim basis through CY 2010, we had ongoing concerns about the methodology used by the AMA RUC to review these services. We requested that the AMA RUC reexamine the Site-of-Service anomaly codes and use the building block methodology to revalue the services (74 FR 62777 and 75 FR 73221). CPT codes 49507, 49521, and 49587 were among those CY 2010 Site-of-Service anomaly codes, and were reviewed again by the AMA RUC as a part of the Fourth Five-Year Review.</P>
          <P>For CPT code 49507 (Repair initial inguinal hernia, age 5 years or over; incarcerated or strangulated), the AMA RUC used magnitude estimation and recommended a work RVU of 9.97 for CPT code 49507 for CY 2010, which was slightly higher than the survey 25th percentile value. In CY 2010, while CMS adopted the AMA RUC-recommended work value on an interim final basis and referred the service back to the AMA RUC to be reexamined, the work RVU for CPT code 49507 used under the PFS was increased to 10.05 based on the redistribution of RVUs that resulted from the CMS policy to no longer recognize the CPT consultation codes. Upon re-review for CY 2012 as part of the Fourth Five-Year Review of Work, the AMA RUC determined that CPT code 49507 had been accurately valued in its recommendation for CY 2010 with support from reference services and specialty survey data, and stated that it found no compelling evidence to change the current physician work value of this service. The AMA RUC ultimately recommended that the current work RVU of 10.05 be maintained for CPT code 49507 for CY 2012.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 10.05 for CPT code 49507. The AMA RUC indicated in its summary of recommendations that the survey data show Ninety-eight percent of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 17 percent stated that the patient is “discharged the same day,” 40 percent stated the patient is “kept overnight (less than 24 hours),” and 43 percent stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent PFS claims data, CPT code 49507 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 9.09 with refinements to the time for CPT code 49507 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 49521 (Repair recurrent inguinal hernia, any age; incarcerated or strangulated), the AMA RUC used magnitude estimation and recommended a work RVU of 12.36 for CY 2010, which fell between the survey 25th percentile and median work value estimates. In CY 2010, while CMS adopted the AMA RUC-recommended work value on an interim final basis and referred the service back to the AMA RUC to be reexamined, the work RVU for CPT code 49521 used under the PFS was increased to 12.44 based on the redistribution of RVUs that resulted from the CMS policy to no longer recognize the CPT consultation codes. Upon re-review for CY 2012, the AMA RUC determined that CPT code 49521 was accurately valued in its recommendation for CY 2010, with support from reference services and specialty survey data, and stated that it found no compelling evidence to change the current physician work value of this service. The AMA RUC ultimately recommended that the current work RVU of 12.44 be maintained for CPT code 49521 in CY 2012.</P>

          <P>We disagree with the AMA RUC-recommended work RVU of 12.44 for CPT code 49521. The AMA RUC indicated in its summary of recommendations that the survey data show 99 percent of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 18 percent stated that the patient is “discharged the same day,” 37 percent stated the patient is “kept overnight (less than 24 hours),” and 45 percent stated the patient is “admitted (more than 24 hours).” These responses make no distinction between<PRTPAGE P="32450"/>the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent PFS claims data, CPT code 49521 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 11.48 with refinements to the time for CPT code 49521 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 49587 (Repair umbilical hernia, age 5 years or over; incarcerated or strangulated), the AMA RUC used magnitude estimation and recommended a work RVU of 7.96 for CY 2010, which was slightly below the survey 25th percentile physician work value estimate. Under the CY 2010 PFS, the work RVU for CPT code 49587 was increased to 8.04 based on the redistribution of RVUs resulting from the CMS policy to no longer recognize the CPT consultation codes. Upon re-review for CY 2012, the AMA RUC determined that CPT code 49587 was accurately valued in its CY 2010 recommendation, with support from reference services and specialty survey data, and stated that it found no compelling evidence to change the current physician work value of this service. The AMA RUC ultimately recommended that the current work RVU of 8.04 be maintained for CPT code 49587 for CY 2012.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 8.04 for CPT code 49587. The AMA RUC indicated in its summary of recommendations that the survey data show 100 percent of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 30 percent stated that the patient is “discharged the same day,” 42 percent stated the patient is “kept overnight (less than 24 hours),” and 29 percent stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent PFS claims data, CPT code 49587 is a code with a Site-of-Service anomaly. Therefore, in accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 7.08 with refinements to the time for CPT code 49587 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">19. Laparoscopic Hernia Repair</HD>
          <GPH DEEP="101" SPAN="3">
            <GID>EP06JN11.038</GID>
          </GPH>
          <P>For CY 2009, the CPT Editorial Panel created six new CPT codes to describe the specific levels of work associated with abdominal hernia repairs that are performed frequently with laparoscopic techniques. We accepted the AMA RUC's original work RVU recommendation for these services for CY 2009. However, we identified 4 of these laparoscopic hernia repair CPT codes, specifically CPT codes 49652, 49653, 49654 and 49655, as potentially misvalued through the Site-of-Service Anomaly screen, and requested that they be reviewed by the AMA RUC for Fourth Five-Year Review.</P>
          <P>For CPT code 49652 (Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia (includes mesh insertion, when performed); reducible), for CY 2009, the AMA RUC used magnitude estimation and recommended the survey 25th percentile work RVU of 12.80 for CPT code 49652 for CY 2009. CMS accepted this recommendation. For CY 2010, the work RVU for CPT code 49652 was increased to 12.88 based on the redistribution of RVUs resulting from the CMS policy to no longer recognize the CPT consultation codes. Upon re-review for CY 2012, the AMA RUC determined that CPT code 49652 was accurately valued in its recommendation for CY 2009, with support from reference services and specialty survey data, and stated that it found no compelling evidence to change the current physician work value of this service. The AMA RUC ultimately recommended that the current work RVU of 12.88 be maintained for CPT code 49652 for CY 2012.</P>

          <P>We disagree with the AMA RUC-recommended work RVU of 12.88 for CPT code 49652. The AMA RUC indicated in its summary of recommendations that the survey data show 100 percent of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 16 percent stated that the patient is “discharged the same day,” 60 percent stated the patient is “kept overnight (less than 24 hours),” and 24 percent stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent PFS claims data, CPT code 49652 is a code with a Site-of-Service anomaly. In its recommendation to us, the AMA RUC asserted that Medicare claims data for this service are still new and may not reflect accurate Medicare utilization for this procedure. The most recent PFS claims data show that outpatient utilization for this code is well above the Site-of-Service anomaly threshold of greater than 50 percent, and we will continue to monitor the data to ensure that this CPT code, and all CPT codes, are valued appropriately for their site-of-service. In accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 11.92 with refinements to the time for CPT code 49652 for CY 2012. A<PRTPAGE P="32451"/>complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 49653 (Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia (includes mesh insertion, when performed); incarcerated or strangulated), for CY 2009, the AMA RUC used magnitude estimation and recommended the survey 25th percentile work RVU of 16.10 for CPT code 49653 for CY 2009. CMS accepted this recommendation. For CY 2010, the work RVU for CPT code 49653 was increased to 16.21 based on the redistribution of RVUs resulting from the CMS policy to no longer recognize the CPT consultation codes. Upon re-review for CY 2012, the AMA RUC determined that CPT code 49653 was accurately valued in its CY 2009 recommendation, with support from reference services and specialty survey data, and stated that it found no compelling evidence to change the current physician work value of this service. The AMA RUC ultimately recommended that the current work RVU of 16.21 be maintained for CPT code 49653 for CY 2012.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 16.21 for CPT code 49653. The AMA RUC indicated in its summary of recommendations that the survey data show 100 percent of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 9 percent stated that the patient is “discharged the same day,” 16 percent stated the patient is “kept overnight (less than 24 hours),” and 76 percent stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent PFS claims data, CPT code 49653 is a code with a Site-of-Service anomaly. In its recommendation to us, the AMA RUC asserted that Medicare claims data for this service are still new and may not reflect accurate Medicare utilization for this procedure. The most recent PFS claims data show that outpatient utilization for this code is well above the Site-of-Service anomaly threshold of greater than 50 percent, and we will continue to monitor the data to ensure that this CPT code, and all CPT codes, are valued appropriately for their site-of-service. In accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 14.94 with refinements to the time for CPT code 49653 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 49654 (Laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed); reducible), for CY 2009 the AMA RUC used magnitude estimation and recommended the survey 25th percentile work RVU of 14.95 for CPT code 49654 for CY 2009. We accepted this recommendation. For CY 2010, the work RVU for CPT code 49654 was increased to 15.03 based on the redistribution of RVUs resulting from the CMS policy to no longer recognize the CPT consultation codes. Upon re-review for CY 2012, the AMA RUC determined that CPT code 49654 was accurately valued in its CY 2009 recommendation, with support from reference services and specialty survey data, and stated that it found no compelling evidence to change the current physician work value of this service. The AMA RUC ultimately recommended that the current work RVU of 15.03 be maintained for CPT code 49654 for CY 2012.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 15.03 for CPT code 49654. The AMA RUC indicated in its summary of recommendations that the survey data show 100 percent of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 10 percent stated that the patient is “discharged the same day,” 33 percent stated the patient is “kept overnight (less than 24 hours),” and 56 percent stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent PFS claims data, CPT code 49654 is a code with a Site-of-Service anomaly. In its recommendation to us, the AMA RUC asserted that Medicare claims data for this service are still new and may not reflect accurate Medicare utilization for this procedure. The most recent PFS claims data show that outpatient utilization for this code is well above the Site-of-Service anomaly threshold of greater than 50 percent, and we will continue to monitor the data to ensure that this CPT code, and all CPT codes, are valued appropriately for their site-of-service. In accordance with the policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 13.76 with refinements to the time for CPT code 49654 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>

          <P>For CPT code 49655 (Laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed); incarcerated or strangulated), for CY 2009 the AMA RUC crosswalked CPT code 49655 to CPT code 43280 (Laparoscopy, surgical, esophagogastric fundoplasty (<E T="03">e.g.,</E>Nissen, Toupet procedures)) (work RVU = 18.10), and recommended a work RVU of 18.00. We accepted this recommendation. For CY 2010, the work RVU for CPT code 49655 was increased to 18.11 based on the redistribution of RVUs resulting from the CMS policy to no longer recognize the CPT consultation codes. Upon re-review for CY 2012, the AMA RUC decided that CPT code 49655 was accurately valued in its CY 2009 recommendation, with support from reference services and specialty survey data, and stated that it found no compelling evidence to change the current physician work value of this service. The AMA RUC ultimately recommended that the current work RVU of 18.11 be maintained for CPT code 49655 for CY 2012.</P>

          <P>We disagree with the AMA RUC-recommended work RVU of 18.11 for CPT code 49655. The AMA RUC indicated in its summary of recommendations that the survey data show 100 percent of survey respondents stated they perform the procedure “in the hospital.” Of those respondents who stated that they typically perform the procedure in the hospital, 5 percent stated that the patient is “discharged the same day,” 8 percent stated the patient is “kept overnight (less than 24 hours),” and 87 percent stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As indicated by the most recent PFS claims data, CPT code 49655 is a code with a Site-of-Service anomaly. In its recommendation to us, the AMA RUC asserted that Medicare claims data for this service are still new and may not reflect accurate Medicare utilization for this procedure. The most recent PFS claims data show that outpatient utilization for this code is above the Site-of-Service anomaly threshold of greater than 50 percent, and we will continue to monitor the data to ensure that this CPT code, and all CPT codes, are valued appropriately for their site-of-service. In accordance with the<PRTPAGE P="32452"/>policy discussed in section II.A. of this proposed notice, we removed the subsequent observation care service, reduced the discharge day management service to one-half, and adjusted times. As a result, we are proposing an alternative work RVU of 16.84 with refinements to the time for CPT code 49655 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">20. Urologic Procedures</HD>
          <GPH DEEP="207" SPAN="3">
            <GID>EP06JN11.039</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 51705, 52005 and 52310 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen. CPT codes 51710, 52007 and 52315 were added as part of the family of services for AMA RUC review. In addition, we identified CPT codes 52630, 52649, 53440 and 57288 as potentially misvalued through the Site-of-Service Anomaly screen. The specialty agreed to add CPT codes 52640 and 57287 as part of the family of services for AMA RUC review.</P>
          <P>For CPT code 51710 (Change of cystostomy tube; complicated), the AMA RUC noted that a request was sent to CMS to have the global service period changed from a 10-day global period (which includes RVUs for the same day pre-operative period and for a 10-day post-operative period) to a 0-day global period (which only includes RVUs for the same day pre- and post-operative period). The AMA RUC indicated that in the standards of care for this procedure, there is no hospital time and there are no follow up visits. The AMA RUC also noted that while the service was surveyed as a 10-day global, the respondents inadvertently included a hospital visit, CPT code 99231(Subsequent hospital care), and overvalued the physician work. Consequently, the AMA RUC did not use the survey results to value the code. Rather, comparing the physician work within the family of services, the AMA RUC compared CPT code 51710 to CPT code 51705 (Change of cystostomy tube; simple) and recommended a work RVU of 1.35 for CPT code 51710.</P>
          <P>We agree with the AMA RUC's recommended work RVU and are proposing a work RVU of 1.35 for CPT code 51710 for CY 2012. We also agree to change the global period from 10 to zero days. However, we note that while we believe that changing a cystostomy tube in a complicated patient may be more time consuming than in a patient that requires a simple cystostomy tube change, we believe that the pre-positioning time is unnecessarily high given the recommended pre-positioning time of 5 minutes for CPT code 51705, which has an identical pre-positioning work description. Hence, we are making refinements in time for CPT code 51710 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 52630 (Transurethral resection; residual or regrowth of obstructive prostate tissue including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included)), the AMA RUC reviewed the survey results and recommended that this service be valued as a service performed predominately in the facility setting, as the survey data indicated that a majority of patients have an overnight stay. Because the majority of respondents stated that the typical patient would be kept overnight in the hospital, the AMA RUC recommended that one inpatient hospital visit and a full day discharge management service be included in the value of the service for CPT code 52630. The AMA RUC stated that it ultimately did not believe there was compelling evidence to signal a recent change in physician work. Accordingly, the AMA RUC recommended maintaining the current work RVU of 7.73 for CPT code 52630.</P>

          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 52630. While the survey data show 93 percent (37 out of 40) of survey respondents stated they perform the procedure “in the hospital,” of those respondents who stated that they typically perform the procedure in the hospital, 3 percent (1 out of 40) stated that the patient is “discharged the same day,” 43 percent (17 out of 40) stated the patient is “kept overnight (less than 24 hours),” and 54 percent (22 out of 40) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. As we discussed in section II.A. of this proposed notice, we believe that the 23-hour stay issue encompasses several scenarios. The typical patient is commonly in the hospital for less than 24 hours, which often means the patient may indeed stay overnight in the hospital. On occasion, the patient may stay longer than a single night in the<PRTPAGE P="32453"/>hospital; however, in both cases, the patient is considered for Medicare purposes to be a hospital outpatient, not an inpatient. Given that the most recent Medicare PFS claims data indicate this service is typically (more than 50 percent of the time) furnished in the outpatient setting, we believe it is appropriate to remove the post-procedure inpatient visit remaining in the AMA RUC-recommended value and adjust the physician times accordingly. We also reduced the discharge day management service to one-half. We are thus proposing an alternative work RVU of 6.55 with refinements in time for CPT code 47563 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 52649 (Laser enucleation of the prostate with morcellation, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)), a Site-of-Service anomaly code, the AMA RUC reviewed the survey results of 16 (out of a sample size of 869) physicians. The AMA RUC recommended that this service be valued as a service performed predominately in the facility setting. Using magnitude estimation, the AMA RUC agreed that the 25th percentile survey value, which is lower than the current work RVU, was appropriate. The AMA RUC ultimately recommended a work RVU of 15.20 for CPT code 52649.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 52649. While the survey data show 94 percent (15 out of 16) of survey respondents stated they perform the procedure “in the hospital,” of those respondents who stated that they typically perform the procedure in the hospital, 33 percent (5 out of 16) stated that the patient is “discharged the same day,” 54 percent (9 out of 16) stated the patient is “kept overnight (less than 24 hours),” and 13 percent (2 out of 16) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. Nevertheless, the survey data confirm the most recent Medicare PFS claims data which show that CPT code 52649 is a code with a Site-of-Service anomaly. Accordingly, we applied our policy for a 23-hour stay service and reduced the discharge day management service to one-half. We are proposing an alternative work RVU of 14.56 with refinements in time for CPT code 52649 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 53440 (Sling operation for correction of male urinary incontinence (eg, fascia or synthetic)), the AMA RUC reviewed the survey results from 30 (out of a sample size of 717) physicians. The AMA RUC recommended that this service be valued as a service performed predominately in the facility setting. Using magnitude estimation, the AMA RUC agreed that the median survey value, which is lower than the current work RVU, was appropriate. The AMA RUC ultimately recommended a work RVU of 14.00 for CPT code 53440.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 53440. While the survey data show 97 percent (29 out of 30) of survey respondents stated they perform the procedure “in the hospital,” of those respondents who stated that they typically perform the procedure in the hospital, 38 percent (11 out of 30) stated that the patient is “discharged the same day,” 59 percent (18 out of 30) stated the patient is “kept overnight (less than 24 hours),” and 3 percent (1 out of 30) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. Nevertheless, the survey data show that the vast majority of responders indicated CPT code 53440 is typically performed in the hospital setting as an outpatient rather than an inpatient service. The survey data confirm the most recent Medicare PFS claims data which show that CPT code 53440 is a code with a Site-of-Service anomaly. Accordingly, we applied our policy for a 23-hour stay service and reduced the discharge day management service to one-half. We are proposing an alternative work RVU of 13.36 with refinements in time for CPT code 53440 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">21. Removal of Thyroid/Parathyroid</HD>
          <GPH DEEP="87" SPAN="3">
            <GID>EP06JN11.040</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 60220, 60240 and 60500 as potentially misvalued through the Site-of-Service Anomaly screen.</P>
          <P>For CPT code 60220 (Total thyroid lobectomy, unilateral; with or without isthmusectomy), the AMA RUC reviewed the survey results from 35 (out of a sample size of 118) physicians. The AMA RUC recommended that this service be valued as a service performed predominately in the facility setting. The AMA RUC indicated that since the typical patient is kept overnight, the AMA RUC believes that one inpatient hospital visit as well as one discharge day management service should be maintained in the post-operative visits for this service. Using magnitude estimation, the AMA RUC recommended the current work RVU of 12.37 for CPT code 60220.</P>

          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 60220. While the survey data show 97 percent (34 out of 35) of survey respondents stated they perform the procedure “in the hospital,” of those respondents who stated that they typically perform the procedure in the hospital, 18 percent (6 out of 34) stated that the patient is “discharged the same day,” 79 percent (27 out of 34) stated the patient is “kept overnight (less than 24 hours),” and 3 percent (1 out of 34) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. Nevertheless, the survey data show that the majority of responders<PRTPAGE P="32454"/>indicated CPT code 60220 is typically performed in the hospital setting as an outpatient rather than an inpatient service. The survey data confirm the most recent Medicare PFS claims which show that CPT code 60220 is a code with a Site-of-Service anomaly. Accordingly, in applying the policy for a 23-hour stay service, we removed the hospital visit, reduced the discharge day management service to one-half, and adjusted times. We are proposing an alternative work RVU of 11.19 with refinements in time for CPT code 60220 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 60240 (Thyroidectomy, total or complete), the AMA RUC reviewed the survey results from 35 (out of a sample size of 118) physicians. Using magnitude estimation, the AMA RUC believed that maintaining the current work RVU is appropriate. The AMA RUC ultimately recommended the current work RVU of 16.22 for CPT code 60240.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 60220. Of the 97 percent of respondents that stated they perform the procedure “in the hospital,” 100 percent stated that the patient is either “discharged the same day” or “kept overnight (less than 24 hours).” The survey data confirm the most recent Medicare PFS claims data which show that CPT code 60240 is a code with a Site-of-Service anomaly. Accordingly, we believe it is appropriate to remove the post-procedure inpatient visit remaining in the value and adjust the physician times accordingly. We also reduced the discharge day management service to one-half, consistent with our 23 hour stay service policy. We are proposing an alternative work RVU of 15.04 with refinements in time for CPT code 60240 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 60500 (Parathyroidectomy or exploration of parathyroid(s);), the AMA RUC reviewed the survey results from 35 (out of a sample size of 118) physicians. The AMA RUC recommended that this service be valued as a service performed predominately in the facility setting. The AMA RUC indicated that since the typical patient is kept overnight, the AMA RUC believes that one hospital visit as well as one discharge day management service should be maintained in the post-operative visits for this service. Using magnitude estimation, the AMA RUC ultimately recommended the current work RVU of 16.78 for CPT code 60500.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 60500. While the survey data show 97 percent (34 out of 35) of survey respondents stated they perform the procedure “in the hospital,” of those respondents who stated that they typically perform the procedure in the hospital, 18 percent (6 out of 34) stated that the patient is “discharged the same day,” 44 percent (15 out of 34) stated the patient is “kept overnight (less than 24 hours),” and 38 percent (13 out of 34) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. Nevertheless, the survey data show that the majority of responders indicated CPT code 60500 is typically performed in the hospital setting as an outpatient rather than an inpatient service. The survey data confirm the most recent Medicare PFS claims data which show that CPT code 60500 is a code with a Site-of-Service anomaly. Accordingly, we removed the hospital visit, reduced the discharge day management service to one-half, and adjusted times. We are proposing an alternative work RVU of 15.60 with refinements in time for CPT code 60500 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">22. Implant Neuroelectrodes</HD>
          <GPH DEEP="60" SPAN="3">
            <GID>EP06JN11.041</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, CMS identified CPT code 63655 (Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural) as potentially misvalued through the Site-of-Service Anomaly screen. CY 2009 Medicare PFS claims data indicated that for the typical case (greater than 50 percent), this service was not performed in the inpatient hospital setting and, therefore, we requested in the CYs 2010 and 2011 PFS final rules that the AMA RUC review this service again.</P>
          <P>For CPT code 63655 (Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural), the associated specialty societies indicated that this service was recently surveyed and reviewed by the AMA RUC in April 2009 and concluded that there was no reason to believe another survey would result in different data requiring a change in the AMA RUC's previous discussion and recommendation. Accordingly, the AMA RUC recommended maintaining the current work RVU of 11.56, as well as the current physician time components.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 63655. We note that according to the survey data provided by the AMA RUC, of the 90 percent of respondents that stated they perform the procedure “in the hospital,” 18 percent stated that the patient is “discharged the same day” and 55 percent stated that the patient was “kept overnight (less than 24 hours).” Given that the most recently available Medicare PFS claims data continue to show the typical case is not an inpatient, and that the survey data for this code suggest the typical case is a 23 hour stay service, we believe it is appropriate to apply our established policy and reduce the discharge day management service to one-half. We are thus proposing an alternative work RVU of 10.92 with refinements in time for CPT code 63655 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">23. Injection of Anesthetic Agent</HD>
          <GPH DEEP="60" SPAN="3">
            <PRTPAGE P="32455"/>
            <GID>EP06JN11.042</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, CMS identified CPT code 64405 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 64405 (Injection, anesthetic agent; greater occipital nerve), the AMA RUC reviewed the survey results and recommended the median survey work RVU of 1.00 for CPT code 64405.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 64405. We believe this code is comparable to the key reference CPT code 20526 (Injection, therapeutic (eg, local anesthetic, corticosteroid), carpal tunnel) (work RVU = 0.94). Accordingly, we are proposing an alternative work RVU of 0.94 for CPT code 64405 for CY 2012.</P>
          <HD SOURCE="HD3">24. Gastric Emptying Study</HD>
          <GPH DEEP="60" SPAN="3">
            <GID>EP06JN11.043</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT code 78264 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 78264 (Gastric emptying study), the AMA RUC reviewed the survey results and recommended the survey median work RVU of 0.95 for CPT code 78264.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 78264. We believe the 25th percentile survey value is more appropriate based on its similarity in the physician work to other diagnostic tests. Accordingly, we are proposing an alternative work RVU of 0.80 for CPT code 78264 for CY 2012.</P>
          <HD SOURCE="HD3">25. Nasopharyngoscopy</HD>
          <GPH DEEP="60" SPAN="3">
            <GID>EP06JN11.044</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT code 92511 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 92511 (Nasopharyngoscopy with endoscope (separate procedure)), the AMA RUC reviewed the survey results of 30 (out of a sample size of 100) physicians. The AMA RUC noted that there is typically an E/M service furnished on the same day as this service. AMA RUC indicated that it believes the survey data overestimated the physician work involved in the surveyed code and recommended that for CPT code 92511, a direct work RVU crosswalk to CPT code 69210 (Removal impacted cerumen (separate procedure), 1 or both ears) was appropriate. Accordingly, the AMA RUC recommended a work RVU of 0.61 for CPT code 92511.</P>
          <P>We agree with the AMA RUC's recommended work RVU and are proposing a work RVU of 0.61 for CPT code 92511 for CY 2012. However, while the AMA RUC noted that there is typically an E/M service furnished on the same day as this service, we are concerned that the times in the surveyed code were not adjusted to account for the overlap in times. The most currently available Medicare PFS claims data continue to show that CPT code 92511 is commonly billed with an E/M visit on the same day; therefore, as described in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. We believe that 4 minutes pre-service evaluation time and 3 minutes post-service time accurately reflect the time required to conduct the work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">26. Cardiopulmonary Resuscitation</HD>
          <GPH DEEP="60" SPAN="3">
            <GID>EP06JN11.045</GID>
          </GPH>
          <PRTPAGE P="32456"/>
          <P>In the Fourth Five-Year Review, CMS identified CPT code 92950 as potentially misvalued through the Harvard-Valued—Utilization &gt;30,000 screen.</P>
          <P>For CPT code 92950 (Cardiopulmonary resuscitation (eg, in cardiac arrest)), the AMA RUC reviewed the survey results recommended the median survey work RVU of 4.50 for CPT code 92950.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 92950. We recognize that patients that undergo this service are very ill; however, we do not believe that the typical patient meets all the criteria for the critical care codes. Furthermore, the most currently available Medicare PFS claims data show that CPT code 92950 is typically performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post service time by one-third. We believe that 1 minute pre-service evaluation time and 20 minutes post-service time accurately reflect the time required to conduct the work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">27. Osteopathic Manipulative Treatment</HD>
          <GPH DEEP="114" SPAN="3">
            <GID>EP06JN11.046</GID>
          </GPH>
          <BILCOD>BILLING CODE C</BILCOD>
          <P>In the Fourth Five-Year Review, we identified CPT codes 98925, 98928 and 98929 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen. Additionally, the American Osteopathic Association identified CPT codes 98926 and 98927 to be reviewed as part of this family since these were also identified to be reviewed by the AMA RUC Relativity Assessment Workgroup because these codes were identified through the Harvard-Valued—Utilization &gt; 100,000 screen.</P>
          <P>For CPT code 98925 (Osteopathic manipulative treatment (OMT); 1-2 body regions involved), the AMA RUC reviewed the survey results and, based on comparisons to reference codes, recommended a work RVU of 0.50 for CPT code 98925.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 0.50 for CPT code 98925 and believe that a work RVU of 0.46 is more appropriate for this service. We are also refining the time associated with this code. Recent PFS claims data show that this service is typically performed on the same day as an E/M visit. The AMA RUC considered this, and determined that the work associated with the pre- and post-service time for CPT code 98925 is separate from the work conducted during the E/M visit. While we understand that these services have differences, we believe some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by<FR>1/3</FR>. We believe that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflect the time required to conduct the work associated with this service.</P>
          <P>In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 0.50. For CPT code 98925, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of .04 of a work RVU, resulting in a work RVU of 0.46. We noted that 70 percent of the survey respondents indicated that the work of performing this service has not changed in the past 5 years (current RVU = 0.45). We are proposing an alternative work RVU of 0.46, with refinement in time for CPT code 98925 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 98926 (Osteopathic manipulative treatment (OMT); 3-4 body regions involved), the AMA RUC reviewed the survey results and determined that the survey 25th percentile work RVU of 0.75 provides the appropriate incremental difference between this CPT code and others in the family, considering the additional intra-service time required for the additional body regions involved. Therefore, the AMA RUC recommended a work RVU of 0.75 for CPT code 98926.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 0.75 for CPT code 98926 and believe that a work RVU of 0.71 is more appropriate for this service. We are also refining the time associated with this code. Recent PFS claims data show that this service is typically performed on the same day as an E/M visit. The AMA RUC considered this, and determined that the work associated with the pre- and post-service time for CPT code 98926 is separate from the work conducted during the E/M visit. While we understand that these services have differences, we believe some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by<FR>1/3</FR>. We believe that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflect the time required to conduct the work associated with this service.</P>

          <P>In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the<PRTPAGE P="32457"/>extracted time and subtracted it from the AMA RUC-recommended work RVU of 0.75. For CPT code 98926, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of .04 of a work RVU, resulting in a work RVU of 0.71. We noted that 81 percent of the survey respondents indicated that the work of performing this service has not changed in the past 5 years (current RVU = 0.65). We are proposing an alternative work RVU of 0.71, with refinement in time for CPT code 98926 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 98927 (Osteopathic manipulative treatment (OMT); 5-6 body regions involved), the AMA RUC reviewed the survey results and determined that a work RVU of 1.00 provides the appropriate incremental difference between this CPT code and others in the family, considering the additional intra-service time required for the additional body regions involved. The AMA RUC stated that this value is supported by the survey 25th percentile work RVU of 0.97. The AMA RUC recommended a work RVU of 1.00 for CPT code 98927.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 1.00 for CPT code 98927 and believe that a work RVU of 0.96 is more appropriate for this service. We are also refining the time associated with this code. Recent PFS claims data show that this service is typically performed on the same day as an E/M visit. The AMA RUC considered this, and determined that the work associated with the pre- and post-service time for CPT code 98927 is separate from the work conducted during the E/M visit. While we understand that these services have differences, we believe some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by<FR>1/3</FR>. We believe that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflect the time required to conduct the work associated with this service.</P>
          <P>In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 1.00. For CPT code 98927, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of .04 of a work RVU, resulting in a work RVU of 0.96. We noted that 77 percent of the survey respondents indicated that the work of performing this service has not changed in the past 5 years (current RVU = 0.87). We are proposing an alternative work RVU of 0.96, with refinement in time for CPT code 98927 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 98928 (Osteopathic manipulative treatment (OMT); 7-8 body regions involved), the AMA RUC reviewed the survey results and determined that a work RVU of 1.25 provides the appropriate incremental difference between this CPT code and others in the family, considering the additional intra-service time required for the additional body regions involved. The AMA RUC stated that this value is supported by the survey 25th percentile work RVU of 1.29. The AMA RUC recommended a work RVU of 1.25 for CPT code 98928.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 1.25 for CPT code 98928 and believe that a work RVU of 1.21 is more appropriate for this service. We are also refining the time associated with this code. Recent PFS claims data show that this service is typically performed on the same day as an E/M visit. The AMA RUC considered this, and determined that the work associated with the pre- and post-service time for CPT code 98928 is separate from the work conducted during the E/M visit. While we understand that these services have differences, we believe some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by<FR>1/3</FR>. We believe that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflect the time required to conduct the work associated with this service.</P>
          <P>In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 1.25. For CPT code 98928, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of .04 of a work RVU, resulting in a work RVU of 1.21. We noted that 67 percent of the survey respondents indicated that the work of performing this service has not changed in the past 5 years (current RVU = 1.03). We are proposing an alternative work RVU of 1.21, with refinement in time for CPT code 98928 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 98929 (Osteopathic manipulative treatment (OMT); 9-10 body regions involved), the AMA RUC reviewed the survey results and determined that the survey 25th percentile work RVU of 1.50 provides the appropriate incremental difference between this CPT code and others in the family, considering the additional intra-service time required for the additional body regions involved. The AMA RUC recommended a work RVU of 1.50 for CPT code 98929.</P>
          <P>We disagree with the AMA RUC-recommended work RVU of 1.50 for CPT code 98929 and believe that a work RVU of 1.46 is more appropriate for this service. We are also refining the time associated with this code. Recent PFS claims data show that this service is typically performed on the same day as an E/M visit. The AMA RUC considered this, and determined that the work associated with the pre- and post-service time for CPT code 98929 is separate from the work conducted during the E/M visit. While we understand that these services have differences, we believe some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by<FR>1/3</FR>. We believe that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflect the time required to conduct the work associated with this service.</P>

          <P>In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 1.50. For CPT code 98929, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of .04 of a work RVU, resulting in a work RVU of 1.46. We noted that 63 percent of the survey respondents indicated that the work of performing this service has not changed in the past<PRTPAGE P="32458"/>5 years (current RVU = 1.19). We are proposing an alternative work RVU of 1.46, with refinement in time for CPT code 98929 for CY 2012. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD3">28. Observation Care</HD>
          <GPH DEEP="127" SPAN="3">
            <GID>EP06JN11.047</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, CMS identified CPT codes 99218 through 99220 as potentially misvalued through the Harvard-Valued—Utilization &gt; 30,000 screen. The American College of Physicians (ACEP) also submitted a public comment identifying CPT codes 99218 through 99220 to be reviewed in the Fourth Five-Year Review. The American College of Emergency Physicians (ACEP) also identified CPT codes 99234 through 99236 as part of the family of services for AMA RUC review.</P>
          <P>For CPT codes 99218 (Level 1 initial observation care, per day), 99219 (Level 2 initial observation care, per day), and 99220 (Level 3 initial observation care, per day), the AMA RUC believes that the patient population has changed for the initial observation care codes. The AMA RUC also believes that a rank order anomaly exists within this family of codes as the observation care codes have an analogous relationship to the initial hospital care codes (99221 through 99223). In October 2009, the AMA RUC considered three new CPT codes for subsequent observation care services and recommended a direct crosswalk to the corresponding level of subsequent hospital care codes (99231 through 99233) for the work RVU. The AMA RUC determined that similarly, the initial observation codes should be valued equivalently to the corresponding initial hospital care codes (99221 through 99223), which includes physician times and work RVUs. Accordingly, for CPT codes 99218-99220, the AMA RUC reviewed the survey results and recommended work RVUs of 1.92 for code 99218, 2.60 for code 99219, and 3.56 for code 99220 for CY 2012.</P>
          <P>We disagree with the AMA RUC-recommended work RVU for CPT code 99218, 99219, and 99220. We agree with the AMA RUC that appropriate relativity must be maintained within and between the families of similar codes. However, we believe that while the work RVUs of these initial observation care codes (99218, 99219, and 99220) should be greater than those of the subsequent observation care codes (99224, 99225, and 99226), we do not believe the work RVUs of the initial observation care codes (99218, 99219, and 99220) should be equivalent (or close) to the initial hospital care codes (99221, 99222, and 99223). We note that in the CY 2011 PFS final rule with comment period (75 FR 73334), we reviewed the new subsequent observation care codes, assigning the following work RVUs on an interim final basis for CY 2011: 0.54 to CPT code 99224, 0.96 to CPT code 99225, and 1.44 to CPT code 99226. These are all lower work RVUs than the subsequent hospital care codes (99224, 99225, and 99226). Furthermore, we noted that CMS has stated previously that in only rare and exceptional cases would reasonable and necessary outpatient observation services span more than 48 hours. In the majority of cases, the decision whether to discharge a patient from the hospital following resolution of the reason for the observation care or to admit the patient as an inpatient can be made in less than 48 hours, usually in less than 24 hours. Consequently, we believe that the acuity level of the typical patient receiving outpatient observation services would generally be lower than that of the inpatient level. We believe that if the patient's acuity level is determined to be at the level of the inpatient, the patient should be admitted to the hospital as an inpatient. We note that CMS has publicly stated in a recent letter to the AHA that “it is not in the hospital's or the beneficiary's interest to extend observation care rather than either releasing the patient from the hospital or admitting the patient as an inpatient * * *” (75 FR 73334).</P>
          <P>Consequently, we are not accepting the AMA RUC's recommendation to value the initial observation care codes at (for CPT Codes 99218 and 99219), or close to (for CPT code 99220) the level of initial hospital care services. Instead, we believe the work RVUs of the initial observation care codes should reflect the modest differences in patient acuity between the outpatient and inpatient settings. We compared the current work RVUs of the initial observation care codes to the interim final work RVUs of the subsequent observation care codes and found that the current relativity existing between these codes is acceptable. We also believe that the current work RVUs of the initial observation care codes maintain the proper rank order with the initial hospital care services. Therefore, we are proposing to maintain the following work RVUs for the initial observation care codes for CY 2012: 1.28 for CPT code 99218, 2.14 for CPT code 99219, and 2.99 for CPT code 99220. We note we are accepting the survey median physician times for these codes, as recommended by the AMA RUC. A complete list of CMS time refinements can be found in Table 6.</P>

          <P>For CPT codes 99234 (Level 1, observation or inpatient hospital care, for the evaluation and management of a patient including admission and discharge on the same date); 99235 (Level 2, observation or inpatient hospital care, for the evaluation and management of a patient including admission and discharge on the same date); and 99236 (Level 3 observation or inpatient hospital care, for the evaluation and management of a patient<PRTPAGE P="32459"/>including admission and discharge on the same date), the AMA RUC reviewed the survey results from 50 internal medicine, family, geriatric, and emergency physicians. The specialty societies indicated and the AMA RUC agreed that survey results appeared flawed. The specialty societies determined that the inability to accurately survey the physician time and work required to perform this service was due to the fact that observation same day admit/discharge services are typically performed by hospitalists (primarily internists) or emergency physicians who work in shifts. Therefore, the physician performing the admission is typically not the same physician who performs the discharge and the survey respondents were not including the physician time and work for both parts of the service.</P>
          <P>Consequently, the AMA RUC used a similar methodology as was established to value these services in 1997, by taking the corresponding initial observation care code of the same level, for example, CPT code 99218 (AMA RUC-recommended work RVU = 1.92) plus half the value of a hospital discharge day management service, CPT code 99238 (work RVU = 1.28). Therefore, for CPT code 99234, the AMA RUC recommended maintaining the current work RVU of 2.56, as using the aforementioned methodology produces the same result. For CPT code 99235, the AMA RUC used the corresponding initial observation care code, CPT code 99219 (AMA RUC-recommended work RVU = 2.6) plus half the value of a hospital discharge day management service, CPT code 99238 (work RVU = 1.28) and recommended the work RVU of 3.24, using the aforementioned methodology. Finally, for CPT code 99236, the AMA RUC used the corresponding initial observation care code, CPT code 99220 (AMA RUC-recommended work RVU = 2.6) plus half the value of a hospital discharge day management service, CPT code 99238 (work RVU = 1.28) and recommended the work RVU of 4.2, using the aforementioned methodology.</P>
          <P>We agree with the AMA RUC's approach to valuing these observation same day admit/discharge services; however, we believe that the values for CPT codes 99218, 99219, and 99220 that are incorporated should be the CMS proposed values discussed above rather than the AMA RUC-recommended values. Therefore, using the proposed work RVU of 1.28 for CPT code 99218 and consistent with the aforementioned methodology, we are proposing a work RVU of 1.92 for CPT code 99234 for CY 2012. For CPT code 99235, using the proposed work RVU of 2.14 for CPT code 99219 and applying the methodology, we are proposing a work RVU of 2.78 for CY 2012. Finally, using the proposed work RVU of 2.99 for CPT code 99220 and applying the methodology, we are proposing a work RVU of 3.63 for CPT code 99236 for CY 2012. We also made corresponding physician time changes. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD2">D. HCPAC-Recommended Work RVUs</HD>
          <HD SOURCE="HD3">1. Excision of Nail</HD>
          <GPH DEEP="74" SPAN="3">
            <GID>EP06JN11.048</GID>
          </GPH>
          <P>In the Fourth Five-Year Review, we identified CPT codes 11732 and 11765 as potentially misvalued through Harvard-Valued—Utilization &gt; 30,000 screen.</P>
          <P>For CPT code 11723 (Avulsion of nail plate, partial or complete, simple; each additional nail plate (List separately in addition to code for primary procedure), the HCPAC reviewed the survey data and determined that the survey 25th percentile work RVU with total time of 15 minutes, was appropriate for this service. The HCPAC recommended a work RVU of 0.48 for CPT code 11732.</P>
          <P>We disagree with the HCPAC-recommended work RVU for CPT code 11723 and believe that a work RVU of 0.44 is more appropriate for this service. We compared CPT code 11723 to MPC CPT code 92250 and determined that CPT 92250 was the more appropriate crosswalk. Additionally, we find the HCPAC-recommended decrease in work RVU to be too small, given the recommended reduction in time. Therefore, we are proposing an alternative work RVU of 0.44 for CPT code 11723 for CY 2012.</P>
          <P>In addition to the work RVU adjustment for CPT code 11723, CMS is refining the time associated with this code. While we agree with the stated rationale justifying the 2 minutes pre-service time, we find the recommended 3 minutes post-service time to be excessive. Upon clinical review, we believe that 1 minute post-service time more accurately reflects the time required to conduct the post-service work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <P>For CPT code 11765 (Wedge excision of skin of nail fold (e.g., for ingrown toenail)), the HCPAC reviewed the survey results and determined that the survey median work RVU with total time of 59 minutes was appropriate for this service. The HCPAC recommended a work RVU of 1.48 for CPT code 11765.</P>
          <P>We disagree with the HCPAC-recommended work RVU for CPT code 11765 and believe that a work RVU of 1.22 is more appropriate. We compared CPT code 11765 with reference CPT code 11422, as well as with CPT code 10060 (Incision and drainage of abscess (e.g., carbuncle, suppurative hidradenitis, cutaneous or subcutaneous abscess, cyst, furuncle, or paronychia); simple or single) (work RVU = 1.22), and determined that CPT code 10060 was more similar in intensity and complexity to CPT code 11765, and thus the better comparator code for this service. Therefore, we are proposing an alternative work RVU of 1.22 for CPT code 11765.</P>

          <P>In addition to the work RVU adjustment for CPT code 11765, CMS is refining the time associated with this code. This service is typically performed on the same day as an E/M visit. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described in section II.A. of this proposed notice, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-<PRTPAGE P="32460"/>third. We believe that 11 minutes pre-service evaluation time and 3 minutes post-service time accurately reflect the time required to conduct the work associated with this service. A complete list of CMS time refinements can be found in Table 6.</P>
          <HD SOURCE="HD2">E. CPT Codes Identified Through the Five-Year Review Process, but Not Reviewed by CMS</HD>
          <HD SOURCE="HD3">1. CPT Codes Referred to CPT Editorial Panel</HD>
          <P>The following table lists the CPT codes that were subsequently sent to the CPT Editorial Panel to consider coding changes. Therefore, the work RVUs for these codes are not addressed in this Five-Year Review proposed notice.</P>
          <BILCOD>BILLING CODE P</BILCOD>
          <GPH DEEP="640" SPAN="3">
            <PRTPAGE P="32461"/>
            <GID>EP06JN11.049</GID>
          </GPH>
          <PRTPAGE P="32462"/>
          <HD SOURCE="HD3">2. CPT Codes Withdrawn From the Five-Year Review</HD>
          <P>The following table lists the CPT codes that were subsequently withdrawn from the Five-Year Review at the request of the medical specialty societies who submitted the codes for review in their public comments on the CY 2010 PFS final rule with comment period and with the agreement of the AMA RUC. Therefore, the work RVUs for these codes are not addressed in this Five-Year Review proposed notice.</P>
          <GPH DEEP="239" SPAN="3">
            <GID>EP06JN11.050</GID>
          </GPH>
          <HD SOURCE="HD3">3. CPT Codes That Are Interim Final for CY 2011</HD>
          <P>The following table lists the CPT codes that were identified by CMS through the Five-Year Review process, but were recently addressed in the CY 2011 PFS final rule with comment period. The RVUs for these codes are currently interim final in CY 2011, were subject to public comment on the CY 2011 PFS final rule with comment period, and will be finalized in the CY 2012 PFS final rule with comment period. Two CPT codes on this list, 11040 and 11041, were deleted by the CPT Editorial Panel for CY 2011 and replaced by new CPT codes on this list (11042 through 11047). Therefore, the work RVUs for these codes are not addressed in this Five-Year Review proposed notice.</P>
          <GPH DEEP="490" SPAN="3">
            <PRTPAGE P="32463"/>
            <GID>EP06JN11.051</GID>
          </GPH>
          <HD SOURCE="HD3">4. CPT Codes for Preventive Medicine Services</HD>
          <P>The following table lists the CPT codes that were identified through the Five-Year Review process by commenters on the CY 2010 PFS final rule with comment period, but are preventive medicine services not covered by Medicare under the PFS. The AMA RUC-recommended RVUs associated with these codes are published in Addendum B of this proposed notice for public reference, but have not been reviewed by CMS. Therefore, the work RVUs for these codes are not addressed in this Five-Year Review proposed notice. We note that Medicare covers a range of preventive services, including the initial preventive physical examination (IPPE) (“Welcome to Medicare Visit”) and the annual wellness visit (AWV), as detailed in the PFS CY 2011 final rule with comment period (75 FR 73412).</P>
          <GPH DEEP="199" SPAN="3">
            <PRTPAGE P="32464"/>
            <GID>EP06JN11.052</GID>
          </GPH>
          <BILCOD>BILLING CODE C</BILCOD>
          <HD SOURCE="HD2">F. Resource-Based Practice Expense RVUs</HD>
          <HD SOURCE="HD3">1. Overview</HD>
          <P>Practice expense (PE) is the portion of the resources used in furnishing the service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages but excluding malpractice expenses, as specified in section 1848(c)(1)(B) of the Act. Section 121 of the Social Security Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, required us to develop a methodology for a resource-based system for determining PE RVUs for each physician's service.</P>
          <P>This proposed notice sets forth proposed revisions to work RVUs affecting payment for physicians' services. PE RVUs were not subject to similar review. However, the proposed work RVU changes will have an impact on the development of PE RVUs due to the methodology we use to develop PE RVUs by looking at the direct and indirect physician practice resources involved in furnishing each service. Changes in work RVUs, changes in the intra-service portions of the physician time, and changes in the number or level of postoperative evaluation and management (E/M) visits associated with these services and their global periods result in corresponding changes to the direct PE inputs and other components used in the development of PE RVUs.</P>
          <P>The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs and the ways in which the revisions set forth in this proposed notice alter some of the inputs used in that methodology. We also refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed review of the PE methodology, including examples.</P>
          <HD SOURCE="HD3">2. Practice Expense Methodology</HD>
          <HD SOURCE="HD3">a. Direct Practice Expense</HD>
          <P>We use a “bottom-up” approach to determine the direct PE by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically involved in furnishing each service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are based on our review of recommendations received from the American Medical Association's (AMA's) Relative Value Update Committee (RUC). For a detailed explanation of the bottom-up direct PE methodology, including examples, we refer readers to the Five-Year Review of Work Relative Value Units Under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).</P>
          <HD SOURCE="HD3">b. Indirect Practice Expense per Hour Data</HD>
          <P>We use survey data on indirect practice expenses incurred per hour worked (PE/HR) in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS), which was expanded (relative to the SMS) to include nonphysician practitioners (NPPs) paid under the PFS.</P>
          <P>The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs using a consistent survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and healthcare professional groups. We believe the PPIS is the most comprehensive source of PE survey information available to date. Therefore, we used the PPIS data to update the PE/HR data for almost all of the Medicare-recognized specialties that participated in the survey for the CY 2010 PFS.</P>
          <P>When we changed over to the PPIS data beginning in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we finalized a 4-year transition (75 percent old/25 percent new for CY 2010, 50 percent old/50 percent new for CY 2011, 25 percent old/75 percent new for CY 2012, and 100 percent new for CY 2013) from the previous PE RVUs to the PE RVUs developed using the new PPIS data.</P>

          <P>Section 303 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 1848(c)(2)(H)(i) of the Act, which requires us to use the medical oncology<PRTPAGE P="32465"/>supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.</P>
          <P>We do not use the PPIS data for reproductive endocrinology, sleep medicine, and spine surgery since these specialties are not separately recognized by Medicare, nor do we have a method to blend these data with Medicare-recognized specialty data.</P>
          <P>Supplemental survey data on independent labs, from the College of American Pathologists, were implemented for payments in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments in CY 2007. Neither IDTFs nor independent labs participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.</P>
          <P>Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for medical oncology, independent laboratories, and IDTFs were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data.</P>
          <P>Previously, we have established PE/HR values for certain specialties without SMS or supplemental survey data by cross-walking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead use the PPIS-based PE/HR. We continue to use the previous crosswalks for specialties that did not participate in the PPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more similar to each other with respect to physician time.</P>
          <P>For registered dietician services, the proposed resource-based PE RVUs have been calculated in accordance with the final policy that crosswalks the specialty to the “All Physicians” PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and discussed again in more detail in the CY 2011 PFS final rule with comment period (75 FR 73183).</P>
          <P>As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), CY 2012 is the third year of the 4 year transition to the PE RVUs calculated using the PPIS data. Therefore, in general, the CY 2012 PE RVUs are a 25 percent/75 percent blend of the previous PE RVUs based on the SMS and supplemental survey data and the new PE RVUS developed using the PPIS data as described above. Note that the reductions in the PE RVUs for expensive diagnostic imaging equipment attributable to the change in the equipment utilization rate assumption to 75 percent are not subject to the transition, as discussed in the CY 2011 PFS final rule with comment period (75 FR 73189 through 73192).</P>
          <P>Additionally, the PPIS PE RVU transition will not apply to CPT codes with changes in global periods. As discussed in the CY 2011 PFS final rule with comment period (75 FR 73183), we believe that a change in the global period of a code results in the CPT code describing a different service to which the previous PE RVUs would no longer be relevant when the code is reported for a service furnished with the new global period. The two CPT codes with proposed changes in global period for CY 2012 are: 51705 (Change of cystostomy tube; simple) and 51710 (Change of cystostomy tube; complicated). The global period for each of these codes changed from a 10-day to a 0-day global period.</P>
          <HD SOURCE="HD3">c. Allocation of Practice Expense to Services</HD>
          <P>To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.</P>
          <HD SOURCE="HD3">(1) Direct Costs</HD>
          <P>The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, equipment, and supplies) typically required to provide the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct PE input cost sum of $400 and another service has a direct PE input cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.</P>
          <HD SOURCE="HD3">(2) Indirect Costs</HD>
          <P>Section II.F.2.b. of this proposed notice describes the current data sources for specialty-specific indirect costs used in our PE calculations. We allocate the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the physician work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is described below.</P>
          <P>• For a given service, we use the direct portion of the PE RVUs calculated as described above and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that perform the service to determine an initial indirect allocator. For example, if the direct portion of the PE RVUs for a given service were 2.00 and direct costs, on average, represented 25 percent of total costs for the specialties that performed the service, the initial indirect allocator would be 6.00 since 2.00 is 25 percent of 8.00.</P>
          <P>• We then add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 6.00 plus 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.</P>
          <P>• We next incorporate the specialty-specific indirect PE/HR data into the calculation. As a relatively extreme example for the sake of simplicity, assume in our example above that, based on the survey data, the average indirect cost of the specialties performing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties performing the second service with an indirect allocator of 5.00. In this case, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.</P>
          <HD SOURCE="HD3">d. Facility and Nonfacility Costs</HD>

          <P>For procedures that can be furnished in a physician's office, as well as in a hospital or other facility setting, we establish two PE RVUs: Facility and nonfacility. The methodology for<PRTPAGE P="32466"/>calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. Because Medicare makes a separate payment to the facility for its costs of furnishing a service, the facility PE RVUs are generally lower than the nonfacility PE RVUs.</P>
          <HD SOURCE="HD3">e. Services With Technical Components and Professional Components</HD>
          <P>Diagnostic services are generally comprised of two components, a professional component (PC) and a technical component (TC), each of which may be performed independently by different providers, or they may be performed together as a “global” service. When services have PC and TC components that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global components, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.)</P>
          <HD SOURCE="HD3">f. Practice Expense RVU Methodology</HD>
          <P>For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746).</P>
          <HD SOURCE="HD3">(1) Setup File</HD>
          <P>First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data from the surveys.</P>
          <HD SOURCE="HD3">(2) Calculate the Direct Cost PE RVUs</HD>
          <P>Sum the costs of each direct input as follows:</P>
          <P>• Step 1: Sum the direct costs of the inputs for each service.</P>
          <P>Apply a scaling adjustment to the direct inputs.</P>
          <P>• Step 2: Calculate the current aggregate pool of direct PE costs. This is the product of the current aggregate PE (aggregate direct and indirect) RVUs, the CF, and the average direct PE percentage from the survey data.</P>
          <P>• Step 3: Calculate the aggregate pool of direct costs. This is the sum of the product of the direct costs for each service from Step 1 and the utilization data for that service.</P>
          <P>• Step 4: Using the results of Step 2 and Step 3 calculate a direct PE scaling adjustment so that the aggregate direct cost pool does not exceed the current aggregate direct cost pool and apply it to the direct costs from Step 1 for each service.</P>
          <P>• Step 5: Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs, as long as the same CF is used in Steps 2 and 5. Different CFs will result in different direct PE scaling factors, but this has no effect on the final direct cost PE RVUs since changes in the CFs and changes in the associated direct scaling factors offset one another.</P>
          <HD SOURCE="HD3">(3) Create the Indirect Cost PE RVUs</HD>
          <P>Create indirect allocators as follows:</P>
          <P>• Step 6: Based on the survey data, calculate direct and indirect PE percentages for each physician specialty.</P>
          <P>• Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global components.</P>
          <P>• Step 8: Calculate the service level allocators for the indirect PE RVUs based on the percentages calculated in Step 7. The indirect PE RVUs are allocated based on the three components: The direct PE RVUs, the clinical PE RVUs, and the work RVUs. For most services the indirect allocator is: Indirect percentage * (direct PE RVUs/direct percentage) + work RVUs.</P>
          <P>There are two situations where this formula is modified as follows:</P>
          <P>• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs + work RVUs.</P>
          <P>• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs.</P>
          <NOTE>
            <HD SOURCE="HED">(Note:</HD>
            <P>For global services, the indirect allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.)</P>
          </NOTE>
          <P>Apply a scaling adjustment to the indirect allocators.</P>
          <P>• Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the current aggregate pool of PE RVUs by the average indirect PE percentage from the survey data.</P>
          <P>• Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service.</P>
          <P>• Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. Calculate the indirect practice cost index.</P>
          <P>• Step 12: Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.</P>
          <P>• Step 13: Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service across all services performed by the specialty.</P>
          <P>• Step 14: Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors.</P>
          <P>• Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty-specific indirect scaling factor by the average indirect scaling factor for the entire PFS.</P>
          <P>• Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global components, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global component.)</P>

          <P>• Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs.<PRTPAGE P="32467"/>
          </P>
          <HD SOURCE="HD3">(4) Calculate the Final PE RVUs</HD>
          <P>• Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment.</P>
          <P>The final PE BN adjustment is calculated by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required primarily because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (See “Specialties excluded from ratesetting calculation” in this section.)</P>
          <HD SOURCE="HD3">(5) Setup File Information</HD>
          <P>Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 7.</P>
          <GPH DEEP="527" SPAN="3">
            <GID>EP06JN11.053</GID>
          </GPH>
          <PRTPAGE P="32468"/>
          <P>• Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.</P>
          <P>• Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.</P>
          <P>• Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).</P>
          <P>• Payment modifiers: Payment modifiers are accounted for in the creation of the file. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier.</P>
          <P>• Work RVUs: The setup file contains the work RVUs from this proposed notice.</P>
          <HD SOURCE="HD3">(6) Equipment Cost per Minute</HD>
          <P>The equipment cost per minute is calculated as:</P>
          
          <FP SOURCE="FP-2">(1/(minutes per year * usage)) * price * ((interest rate/(1−(1/((1 + interest rate)^ life of equipment)))) + maintenance)</FP>
          
          <EXTRACT>
            <FP SOURCE="FP-2">Where:</FP>
            
            <FP SOURCE="FP-2">Minutes per year = maximum minutes per year if usage were continuous (that is, usage = 1); generally 150,000 minutes.</FP>
            <FP SOURCE="FP-2">Usage = equipment utilization assumption; 0.75 for certain expensive diagnostic imaging equipment (see 75 FR 73189 through 73192) and 0.5 for others.</FP>
            <FP SOURCE="FP-2">Price = price of the particular piece of equipment.</FP>
            <FP SOURCE="FP-2">Interest rate = 0.11.</FP>
            <FP SOURCE="FP-2">Life of equipment = useful life of the particular piece of equipment.</FP>
            <FP SOURCE="FP-2">Maintenance = factor for maintenance; 0.05.</FP>
          </EXTRACT>
          <HD SOURCE="HD3">3. Practice Expense RVUs for Codes Included in the Five-Year Review</HD>
          <P>Some direct PE inputs and other components of the PE methodology are directly affected by the proposed revisions in work RVUs and physician time described in section II.C. of this proposed notice. In the following discussion, we detail how changes in work RVUs, changes in the intra-service portions of the physician time, and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs and other components used in the development of PE RVUs.</P>
          <HD SOURCE="HD3">a. Changes to Direct Practice Expense Inputs</HD>

          <P>Proposed changes in the intra-service portions of the physician time, and in the number or level of postoperative visits within the global periods associated with particular codes, result in corresponding changes in the values of certain direct PE inputs (clinical labor time, equipment time, and supply quantity). The following sections present the logic we used in making changes in the direct PE inputs based on their association with physician time. These changes are included in the Five-Year Review of Work proposed notice direct PE database, which is available on the CMS Web site under the downloads for this proposed notice at:<E T="03">http://www.cms.gov/PhysicianFeeSched/.</E>
          </P>
          <HD SOURCE="HD3">(1) Changes in Intra-service Physician Time in the Nonfacility Setting</HD>
          <P>Clinical Labor: For most codes valued in the nonfacility setting, a portion of the clinical labor time allocated to the intra-service period reflects minutes assigned for assisting the physician with the procedure. To the extent that we are proposing changes in the times associated with the intra-service portion of such procedures, we have adjusted the corresponding intra-service clinical labor minutes in the nonfacility setting.</P>
          <P>Equipment Time: For equipment associated with the intra-service period in the nonfacility setting, we generally allocate time based on the typical number of minutes a piece of equipment is being used and, therefore, not available for use with another patient during that period. In general, we allocate these minutes based on the description of typical clinical labor activities. To the extent that we are proposing changes in the clinical labor times associated with the intra-service portion of procedures, we have adjusted the corresponding equipment minutes associated with the codes.</P>
          <HD SOURCE="HD3">(2) Changes in Hospital Discharge Management Services in the Facility Setting</HD>
          <P>Clinical Labor: For most codes with 10 or 90 day global periods that are valued in the facility setting, a portion of the clinical labor time allocated to the intra-service period in the facility setting reflects minutes assigned for discharge day management. To the extent that we are proposing changes in the physician times associated with hospital discharge day management, we have adjusted the corresponding intra-service clinical labor minutes in the facility setting.</P>
          <HD SOURCE="HD3">(3) Changes in the Number or Level of Postoperative Office Visits in the Global Period</HD>
          <P>Clinical Labor: For codes valued with post-service physician office visits during a global period, most of the clinical labor time allocated to the post-service period reflects a standard number of minutes allocated for each of those visits. To the extent that we are proposing a change in the number or level of postoperative visits, we have modified the clinical staff time in the post-service period to reflect the change.</P>
          <P>Equipment Time: For codes valued with post-service physician office visits during a global period, we allocate standard equipment for each of those visits. To the extent that we are proposing a change in the number or level of postoperative visits associated with a code, we have adjusted the corresponding equipment minutes.</P>

          <P>Supplies: For codes valued with post-service physician office visits during a global period, a certain number of supply items are allocated for each of those office visits. To the extent that we are proposing a change in the number of postoperative visits, we have adjusted the corresponding supply item quantities associated with the codes. We note that many supply items associated with post-service physician office visits are allocated for each office visit (for example, a minimum multi-specialty visit pack (SA048) in the proposed notice direct PE database). For these supply items, the quantities in the proposed notice direct PE database should reflect the proposed number of office visits associated with the code's global period. However, some supply items are associated with post-service physician office visits but are only allocated once during the global period because they are typically used during only one of the post-service office visits (for example, pack, post-op incision care (suture) (SA054) in the proposed notice direct PE database). For these supply items, the quantities in the proposed notice direct PE database reflect that single quantity.<PRTPAGE P="32469"/>
          </P>
          <HD SOURCE="HD3">b. Changes in Components of the Indirect Practice Expense Methodology</HD>
          <HD SOURCE="HD3">(1) Work RVUs, Direct PE RVUs, and Clinical Labor PE RVUs</HD>
          <P>In calculating the allocations for indirect PE RVUs, as we describe in section II.F.2.f. of this proposed notice, we calculate the service level allocators for the indirect PEs based on the three components: direct PE RVUs, clinical labor PE RVUs, and work RVUs. Therefore, changes in the values of those components result in corresponding changes in the allocation of indirect PE RVUs.</P>
          <HD SOURCE="HD3">(2) Physician Time</HD>
          <P>Similarly, in creating the indirect practice cost index, as we describe in section II.F.2.f. of this proposed notice, we calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service across all services performed by the specialty. Therefore, changes in the physician time result in corresponding changes in the calculation of specialty-specific aggregate pools of indirect PE for all PFS services for that specialty and consequently, the allocation of indirect PE RVUs.</P>
          <HD SOURCE="HD2">G. Malpractice RVUs</HD>
          <P>Section 1848(c) of the Act requires that each service paid under the PFS be comprised of three components: Work, PE, and malpractice. From 1992 to 1999, malpractice RVUs were charge-based, using weighted specialty-specific malpractice expense percentages and 1991 average allowed charges. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 1848(c)(2)(C)(iii) of the Act required us to implement resource-based malpractice RVUs for services furnished beginning in 2000. Therefore, initial implementation of resource-based malpractice RVUs occurred in 2000.</P>
          <P>The statute also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. The first review and update of resource-based malpractice RVUs was addressed in the CY 2005 PFS final rule with comment period (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). In the CY 2010 PFS final rule with comment period, we implemented the second review and update of malpractice RVUs. For a discussion of the second review and update of malpractice RVUs, see the CY 2010 PFS proposed rule (74 FR 33537) and final rule with comment period (74 FR 61758).</P>
          <P>As established in the CY 2011 PFS final rule with comment period (75 FR 73208), malpractice RVUs for new and revised codes effective before the next Five-Year Review (for example, effective CY 2011 through CY 2014) are determined by a direct crosswalk to a similar “source” code or a modified crosswalk to account for differences in work RVU between the new/revised code and the source code. For the modified crosswalk approach, we adjust the malpractice RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work value (or, if greater, the clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code is 10 percent higher than the work RVU for its source code, the malpractice RVU for the revised code would be increased by 10 percent over the source code RVU. This approach presumes the same risk factor for the new/revised code and source code but uses the work RVU for the new/revised code to adjust for risk-of-service. The assigned malpractice RVUs for new/revised codes effective between updates remain in place until the next Five-Year Review. For this Fourth Five-Year Review, with the exception of 3 CPT codes (33981, 33982, and 33983), the source code for each code reviewed in the Five-Year Review is the code itself. Under this usual circumstance, we calculated the revised malpractice RVU for these codes by scaling the current malpractice RVU by the percent difference in work RVU between the current (CY 2011) work RVU and the work RVU proposed in section II.C. of this proposed notice.</P>
          <P>CPT codes 33981 (Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump); 33982 (Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass); and 33983 (Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass) were previously contractor-priced and do not have current work RVUs. Therefore we applied the AMA RUC-recommended crosswalks to obtain the appropriate malpractice RVUs. The crosswalk source code for CPT code 33981 is CPT code 33976 (Insertion of ventricular assist device; extracorporeal, biventricular), and the crosswalk source for CPT code 33982 and 33983 is CPT code 33979 (Insertion of ventricular assist device, implantable intracorporeal, single ventricle). Consistent with the methodology described above, the malpractice RVUs for these three newly-valued codes were developed by adjusting the malpractice RVU of the source code for the difference in work RVU between the source code and the newly-valued code. All malpractice RVUs are listed in Addendum B of this proposed notice.</P>
          <HD SOURCE="HD2">H. Budget Neutrality</HD>
          <P>Section 1848(c)(2)(B)(ii) of the Act requires that increases or decreases in RVUs for a year may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we must make adjustments to preserve budget neutrality. We estimate that the net effect on the PFS overall from the Fourth Five-Year Review changes discussed in this proposed notice would be under $20 million for CY 2012, as compared to CY 2011, based on CY 2009 Medicare PFS utilization data. The current law estimate of the CY 2012 CF is $23.9396. Since the net impact on the PFS is under the $20 million threshold, we will not apply a budget neutrality adjustment to the CY 2012 conversion factor (CF). We note that additional changes to PFS payment policies, including the establishment of interim and final RVUs for coding changes that will be announced later this year, may result in the application of budget-neutrality adjustments for CY 2012.</P>
          <HD SOURCE="HD1">III. Response to Comments</HD>

          <P>Because of the large number of public comments we normally receive on<E T="04">Federal Register</E>documents, we are not able to acknowledge or respond to them individually. We will consider all comments received by the date and time specified in the<E T="02">DATES</E>section of this preamble, and we will respond to the comments in the CY 2012 PFS final rule with comment period.</P>
          <HD SOURCE="HD1">IV. Collection of Information Requirements</HD>

          <P>This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35)<PRTPAGE P="32470"/>
          </P>
          <HD SOURCE="HD1">V. Regulatory Impact Analysis</HD>
          <HD SOURCE="HD2">A. Overall Impact</HD>
          <P>We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).</P>
          <P>Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate that this proposed notice will redistribute less than $100 million of PFS expenditures in 1 year. Therefore, we estimate that this rulemaking is not “economically significant” as measured by the $100 million threshold, and hence not a major rule under the Congressional Review Act. Accordingly, we are not including a formal regulatory impact analysis.</P>
          <P>While we are not including a formal regulatory impact analysis, we are providing the following discussion for informational purposes. Of the CPT codes reviewed during the Fourth Five-Year Review of Work, there are both proposed increases and decreases in work values and changes in physician time. The changes in work values and physician time values result in corresponding changes to the PE and malpractice RVUs, as discussed in sections II.F.3. and II.G. of this proposed notice. Overall, we estimate that the net effect on PFS spending would be under $20 million for CY 2012, as compared to CY 2011. At the specialty level, this Five-Year Review of Work is estimated to have no significant impact based on the aggregate services that each specialty performed during CY 2009. We note that CY 2009 is the most recent year for which complete PFS utilization data are available at the time of the analysis for this proposed notice.</P>
          <P>The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the SBA definition of a small business (having revenues of less than $7.0 million to $34.5 million in any 1 year). For purposes of the RFA, physicians, nonphysician practitioners (NPPs), and other suppliers, including independent diagnostic testing facilities (IDTFs), are considered small businesses if they generate revenues of $10 million or less based on SBA size standards. Approximately 95 percent of physicians are considered to be small entities. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Since we estimate that there are no significant impacts at the specialty level due to the proposed changes in RVUs resulting from the Fourth Five-Year Review of Work, the Secretary has determined that this proposed notice will not have a significant impact on the operations of a substantial number of small businesses or other small entities. Therefore, the Secretary has determined that this proposed notice will not have a significant economic impact on a substantial number of small entities.</P>
          <P>In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We do not believe that there will be significant impacts on small rural hospitals given the overall insignificant impact attributable to proposed RVU changes resulting from this Five-Year Review of Work. Therefore, the Secretary has determined that this proposed notice will not have a significant impact on the operations of a substantial number of small rural hospitals.</P>
          <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. This proposed notice will not mandate any requirements for State, local, or Tribal governments in the aggregate, or by the private sector, of $135 million. Medicare beneficiaries are considered to be part of the private sector and as a result a more detailed discussion is presented on the Impact of Beneficiaries in section V.C. of this proposed notice.</P>
          <P>Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have examined this proposed notice in accordance with Executive Order 13132 and have determined that this regulation would not have any substantial direct effect on State or local governments, preempt States, or otherwise have a Federalism implication.</P>
          <HD SOURCE="HD2">B. Anticipated Effects: Impact on Beneficiaries</HD>
          <P>Overall, we believe these changes would improve beneficiary access to reasonable and necessary services since services would be more appropriately valued. The payment changes could also affect beneficiary liability. Any changes in aggregate beneficiary liability from a particular work RVU change would be negligible; however, an individual beneficiary's liability would be a function of the coinsurance (20 percent, if applicable, for the particular service after the beneficiary has met the deductible) and the effect of the work RVU changes on the calculation of the Medicare Part B payment rate for the service.</P>
          <HD SOURCE="HD2">C. Alternatives Considered</HD>
          <P>This proposed notice discusses the proposed revisions to the work RVUs and corresponding changes to the PE and malpractice RVUs under the PFS. The preamble provides descriptions of the statutory provisions that are addressed, identifies those areas when discretion has been exercised, presents rationale for our decisions, and where relevant, alternatives that were considered.</P>
          <HD SOURCE="HD2">D. Accounting Statement and Table</HD>
          <P>As required by OMB Circular A-4 (available at<E T="03">http://www.whitehouse.gov/sites/default/files/omb/assets/omb/circulars/a004/a-4.pdf</E>), in Table 8, we have prepared an accounting statement showing the estimated expenditures associated with this proposed notice.</P>
          <GPH DEEP="125" SPAN="3">
            <PRTPAGE P="32471"/>
            <GID>EP06JN11.054</GID>
          </GPH>
          <HD SOURCE="HD2">E. Conclusion</HD>
          <P>As stated previously, the Secretary determined that the economic impacts of this proposed notice do not meet the level required by section 1102(b) of the Act or the RFA and, therefore, we are not providing a regulatory impact analysis.</P>
          <P>In accordance with the provisions of Executive Order 12866, this proposed notice was reviewed by the Office of Management and Budget.</P>
          
          <EXTRACT>
            <FP>(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program)</FP>
          </EXTRACT>
          <SIG>
            <DATED>Dated: March 31, 2011.</DATED>
            <NAME>Donald M. Berwick,</NAME>
            <TITLE>Administrator, Centers for Medicare &amp; Medicaid Services.</TITLE>
            <DATED>Approved: April 28, 2011.</DATED>
            <NAME>Kathleen Sebelius,</NAME>
            <TITLE>Secretary, Department of Health and Human Services.</TITLE>
          </SIG>
          <HD SOURCE="HD1">ADDENDUM A: EXPLANATION AND USE OF ADDENDA B AND C</HD>
          <EXTRACT>
            <P>The Addenda on the following pages provide various data pertaining to the Medicare fee schedule for physicians' services furnished in CY 2012. Addendum B contains the RVUs for work, nonfacility PE, facility PE, and malpractice expense, and other information for all services included in the PFS. We note that for this proposed notice, to create Addendum B, we retained the current CY 2011 RVUs from the CY 2011 payment file for most codes and displayed new RVUs for only those codes involved in the Fourth Five-Year Review of Work. PE RVUs for these Five-Year Review codes were calculated using CY 2009 Medicare utilization data in order to maintain consistency with the current CY 2011 RVUs displayed for all other services. Addendum C contains the list of CPT codes that were reviewed for the Fourth Five-Year Review of Work.</P>
            <P>(1) Addendum B: Relative Value Units and Related Information Used in Determining Payments for CY 2012 (Changes from CY 2011 for Services Reviewed in the Fourth Five-Year Review Only)</P>
            <P>In previous years, we have listed many services in Addendum B that are not paid under the PFS. To avoid publishing as many pages of codes for these services, we are not including clinical laboratory codes or the alpha-numeric codes (Healthcare Common Procedure Coding System (HCPCS) codes not included in CPT) not paid under the PFS in Addendum B.</P>
            <P>Addendum B contains the following information for each CPT code and alpha-numeric HCPCS code, except for: Alpha-numeric codes beginning with B (enteral and parenteral therapy); E (durable medical equipment); K (temporary codes for nonphysicians' services or items); or L (orthotics); and codes for anesthesiology. Please also note the following:</P>
            <P>• An “NA” in the “Nonfacility PE RVUs” column of Addendum B means that CMS has not developed a PE RVU in the nonfacility setting for the service because it is typically performed in the hospital (for example, an open heart surgery is generally performed in the hospital setting and not a physician's office). If there is an “NA” in the nonfacility PE RVU column, and the contractor determines that this service can be performed in the nonfacility setting, the service will be paid at the facility PE RVU rate.</P>
            <P>• Services that have an “NA” in the “Facility PE RVUs” column of Addendum B are typically not paid under the PFS when provided in a facility setting. These services (which include “incident to” services and the technical portion of diagnostic tests) are generally paid under either the hospital outpatient prospective payment system or bundled into the hospital inpatient prospective payment system payment. In some cases, these services may be paid in a facility setting at the PFS rate (for example, therapy services), but there would be no payment made to the practitioner under the PFS in these situations.</P>
            <P>
              <E T="03">1. CPT/HCPCS code.</E>This is the CPT or alpha-numeric HCPCS number for the service. Alpha-numeric HCPCS codes are included at the end of this Addendum.</P>
            <P>
              <E T="03">2. Modifier.</E>A modifier is shown if there is a technical component (modifier TC) and a professional component (PC) (modifier-26) for the service. If there is a PC and a TC for the service, Addendum B contains three entries for the code. A code for: the global values (both professional and technical); modifier-26 (PC); and modifier TC. The global service is not designated by a modifier, and physicians must bill using the code without a modifier if the physician furnishes both the PC and the TC of the service. Modifier-53 is shown for a discontinued procedure, for example, a colonoscopy that is not completed. There will be RVUs for a code with this modifier.</P>
            <P>
              <E T="03">3. Status indicator.</E>This indicator shows whether the CPT/HCPCS code is included in the PFS and whether it is separately payable if the service is covered. An explanation of types of status indicators follows:</P>
            <P>
              <E T="03">A = Active code.</E>These codes are separately payable under the PFS if covered. There will be RVUs for codes with this status. The presence of an “A” indicator does not mean that Medicare has made a national coverage determination regarding the service. Contractors remain responsible for coverage decisions in the absence of a national Medicare policy.</P>
            <P>
              <E T="03">B = Bundled code.</E>Payments for covered services are always bundled into payment for other services not specified. If RVUs are shown, they are not used for Medicare payment. If these services are covered, payment for them is subsumed by the payment for the services to which they are incident (for example, a telephone call from a hospital nurse regarding care of a patient).</P>
            <P>
              <E T="03">C = Contractors price the code.</E>Contractors establish RVUs and payment amounts for these services, generally on an individual case basis following review of documentation, such as an operative report.</P>
            <P>
              <E T="03">E = Excluded from the PFS by regulation.</E>These codes are for items and services that CMS chose to exclude from the PFS by regulation. No RVUs are shown, and no payment may be made under the PFS for these codes. Payment for them, when covered, continues under reasonable charge procedures.</P>
            <P>
              <E T="03">I = Not valid for Medicare purposes.</E>Medicare uses another code for the reporting of, and the payment for these services. (Codes not subject to a 90 day grace period.)</P>
            <P>
              <E T="03">M = Measurement codes, used for reporting purposes only.</E>There are no RVUs and no payment amounts for these codes. CMS uses them to aid with performance measurement. No separate payment is made. These codes should be billed with a zero (($0.00) charge and are denied) on the MPFSDB.</P>
            <P>
              <E T="03">N = Non-covered service.</E>These codes are noncovered services. Medicare payment may not be made for these codes. If RVUs are shown, they are not used for Medicare payment.</P>
            <P>
              <E T="03">R = Restricted coverage.</E>Special coverage instructions apply. If the service is covered and no RVUs are shown, it is contractor-priced.</P>
            <P>
              <E T="03">T = There are RVUs for these services, but they are only paid if there are no other<PRTPAGE P="32472"/>services payable under the PFS billed on the same date by the same provider.</E>If any other services payable under the PFS are billed on the same date by the same provider, these services are bundled into the service(s) for which payment is made.</P>
            <P>
              <E T="03">X = Statutory exclusion.</E>These codes represent an item or service that is not within the statutory definition of “physicians' services” for PFS payment purposes. No RVUs are shown for these codes, and no payment may be made under the PFS, (for example, ambulance services and clinical diagnostic laboratory services.)</P>
            <P>4.<E T="03">Description of code.</E>This is the code's short descriptor, which is an abbreviated version of the narrative description of the code.</P>
            <P>5.<E T="03">Physician work RVUs.</E>These are the RVUs for the physician work in CY 2011.</P>
            <P>6.<E T="03">Fully implemented nonfacility PE RVUs.</E>These are the fully implemented resource-based PE RVUs for nonfacility settings.</P>
            <P>7.<E T="03">CY 2011 transitional nonfacility PE RVUs.</E>These are the CY 2011 resource-based PE RVUs for nonfacility settings.</P>
            <P>8.<E T="03">Fully implemented facility PE RVUs.</E>These are the fully implemented resource-based PE RVUs for facility settings.</P>
            <P>9.<E T="03">CY 2011 Transitional facility PE RVUs.</E>These are the CY 2011 resource-based PE RVUs for facility settings.</P>
            <P>10.<E T="03">Malpractice expense RVUs.</E>These are the RVUs for the malpractice expense for CY 2011.</P>
            <P>11.<E T="03">Global period.</E>This indicator shows the number of days in the global period for the code (0, 10, or 90 days). An explanation of the alpha codes follows:</P>
            <P>MMM = Code describes a service furnished in uncomplicated maternity cases, including ante partum care, delivery, and postpartum care. The usual global surgical concept does not apply. See the Physicians' Current Procedural Terminology for specific definitions.</P>
            <P>XXX = The global concept does not apply.</P>
            <P>YYY = The global period is to be set by the contractor (for example, unlisted surgery codes).</P>
            <P>ZZZ = Code related to another service that is always included in the global period of the other service.</P>
            <HD SOURCE="HD3">(2) Addendum C: Codes With Proposed RVUs Subject to Comment for Fourth Five-Year Review of Work</HD>
            <P>Addendum C includes the columns and indicators described above for Addendum B for codes with proposed RVUs subject to comment for the Fourth Five-Year Review of Work.</P>
            <BILCOD>BILLING CODE P</BILCOD>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32473"/>
              <GID>EP06JN11.057</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32474"/>
              <GID>EP06JN11.058</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32475"/>
              <GID>EP06JN11.059</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32476"/>
              <GID>EP06JN11.060</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32477"/>
              <GID>EP06JN11.061</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32478"/>
              <GID>EP06JN11.062</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32479"/>
              <GID>EP06JN11.063</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32480"/>
              <GID>EP06JN11.064</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32481"/>
              <GID>EP06JN11.065</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32482"/>
              <GID>EP06JN11.066</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32483"/>
              <GID>EP06JN11.067</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32484"/>
              <GID>EP06JN11.068</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32485"/>
              <GID>EP06JN11.069</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32486"/>
              <GID>EP06JN11.070</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32487"/>
              <GID>EP06JN11.071</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32488"/>
              <GID>EP06JN11.072</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32489"/>
              <GID>EP06JN11.073</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32490"/>
              <GID>EP06JN11.074</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32491"/>
              <GID>EP06JN11.075</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32492"/>
              <GID>EP06JN11.076</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32493"/>
              <GID>EP06JN11.077</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32494"/>
              <GID>EP06JN11.078</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32495"/>
              <GID>EP06JN11.079</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32496"/>
              <GID>EP06JN11.080</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32497"/>
              <GID>EP06JN11.081</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32498"/>
              <GID>EP06JN11.082</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32499"/>
              <GID>EP06JN11.083</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32500"/>
              <GID>EP06JN11.084</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32501"/>
              <GID>EP06JN11.085</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32502"/>
              <GID>EP06JN11.086</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32503"/>
              <GID>EP06JN11.087</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32504"/>
              <GID>EP06JN11.088</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32505"/>
              <GID>EP06JN11.089</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32506"/>
              <GID>EP06JN11.090</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32507"/>
              <GID>EP06JN11.091</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32508"/>
              <GID>EP06JN11.092</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32509"/>
              <GID>EP06JN11.093</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32510"/>
              <GID>EP06JN11.094</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32511"/>
              <GID>EP06JN11.095</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32512"/>
              <GID>EP06JN11.096</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32513"/>
              <GID>EP06JN11.097</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32514"/>
              <GID>EP06JN11.098</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32515"/>
              <GID>EP06JN11.099</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
              <PRTPAGE P="32516"/>
              <GID>EP06JN11.100</GID>
            </GPH>
            <GPH DEEP="640" SPAN="3">
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          </EXTRACT>
        </SUPLINF>
        <FRDOC>[FR Doc. 2011-13052 Filed 5-24-11; 4:15 pm]</FRDOC>
        <BILCOD>BILLING CODE C</BILCOD>
      </PRORULE>
    </PRORULES>
  </NEWPART>
  <VOL>76</VOL>
  <NO>108</NO>
  <DATE>Monday, June 6, 2011</DATE>
  <UNITNAME>Rules and Regulations</UNITNAME>
  <NEWPART>
    <PTITLE>
      <PRTPAGE P="32815"/>
      <PARTNO>Part III</PARTNO>
      <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
      <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
      <HRULE/>
      <CFR>42 CFR Parts 434, 438, and 447</CFR>
      <TITLE>Medicaid Program; Payment Adjustment for Provider-Preventable Conditions Including Health Care-Acquired Conditions; Final Rule</TITLE>
    </PTITLE>
    <RULES>
      <RULE>
        <PREAMB>
          <PRTPAGE P="32816"/>
          <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
          <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
          <CFR>42 CFR Parts 434, 438, and 447</CFR>
          <DEPDOC>[CMS-2400-F]</DEPDOC>
          <RIN>RIN 0938-AQ34</RIN>
          <SUBJECT>Medicaid Program; Payment Adjustment for Provider-Preventable Conditions Including Health Care-Acquired Conditions</SUBJECT>
          <AGY>
            <HD SOURCE="HED">AGENCY:</HD>
            <P>Centers for Medicare &amp; Medicaid Services (CMS), HHS.</P>
          </AGY>
          <ACT>
            <HD SOURCE="HED">ACTION:</HD>
            <P>Final rule.</P>
          </ACT>
          <SUM>
            <HD SOURCE="HED">SUMMARY:</HD>
            <P>This final rule will implement section 2702 of the Patient Protection and Affordable Care Act which directs the Secretary of Health and Human Services to issue Medicaid regulations effective as of July 1, 2011 prohibiting Federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions specified in the regulation. It will also authorize States to identify other provider-preventable conditions for which Medicaid payment will be prohibited.</P>
          </SUM>
          <EFFDATE>
            <HD SOURCE="HED">DATES:</HD>
            <P>These regulations are effective on July 1, 2011.</P>
          </EFFDATE>
          <FURINF>
            <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
            <P>Venesa Day, (410) 786-8281, or Marsha Lillie-Blanton, (410) 786-8856.</P>
          </FURINF>
        </PREAMB>
        <SUPLINF>
          <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
          <HD SOURCE="HD1">Acronyms</HD>
          <EXTRACT>
            <P>To assist the reader, the following list of the acronyms are used in this final rule:</P>
            
            <FP SOURCE="FP-1">AHRQAgency for Healthcare Research and Quality</FP>
            <FP SOURCE="FP-1">BPMBenefit Policy Manual</FP>
            <FP SOURCE="FP-1">CABGCoronary artery bypass graft</FP>
            <FP SOURCE="FP-1">CBOCongressional Budget Office</FP>
            <FP SOURCE="FP-1">CDCCenters for Disease Control and Prevention</FP>
            <FP SOURCE="FP-1">DVTDeep vein thrombosis</FP>
            <FP SOURCE="FP-1">ESRDEnd-stage renal disease</FP>
            <FP SOURCE="FP-1">DRADeficit Reduction Act of 2005 (Pub. L. 109-171, enacted on February 8, 2006)</FP>
            <FP SOURCE="FP-1">FFPFederal financial participation</FP>
            <FP SOURCE="FP-1">FYFiscal year</FP>
            <FP SOURCE="FP-1">HACHospital-acquired condition</FP>
            <FP SOURCE="FP-1">HCACHealth care-acquired condition</FP>
            <FP SOURCE="FP-1">ICRInformation collection requirement</FP>
            <FP SOURCE="FP-1">IHInpatient Hospital</FP>
            <FP SOURCE="FP-1">IPPSInpatient prospective payment system</FP>
            <FP SOURCE="FP-1">MS-DRGDiagnosis-related group</FP>
            <FP SOURCE="FP-1">NCANational coverage analysis</FP>
            <FP SOURCE="FP-1">NDCNational coverage determination</FP>
            <FP SOURCE="FP-1">NQFNational Quality Forum</FP>
            <FP SOURCE="FP-1">OACT[CMS] Office of the Actuary</FP>
            <FP SOURCE="FP-1">OIGOffice of Inspector General</FP>
            <FP SOURCE="FP-1">OMBOffice of Management and Budget</FP>
            <FP SOURCE="FP-1">OPPCOther provider-preventable condition</FP>
            <FP SOURCE="FP-1">PEPulmonary embolism</FP>
            <FP SOURCE="FP-1">POAPresent on admission</FP>
            <FP SOURCE="FP-1">PPCProvider-preventable condition</FP>
            <FP SOURCE="FP-1">PRAPaperwork Reduction Act</FP>
            <FP SOURCE="FP-1">RFARegulatory Flexibility Act (September 19, 1980, Pub. L. 96-354)</FP>
            <FP SOURCE="FP-1">RIARegulatory impact analysis</FP>
            <FP SOURCE="FP-1">SMDLState Medicaid Director Letter</FP>
            <FP SOURCE="FP-1">SPAState plan amendment</FP>
            <FP SOURCE="FP-1">UMRAUnfunded Mandates Reform Act of 1995 (Pub. L. 104-04, enacted on March 22, 1995)</FP>
            <FP SOURCE="FP-1">UTIUrinary tract infection</FP>
          </EXTRACT>
          <HD SOURCE="HD1">I. Background</HD>
          <P>Title XIX of the Social Security Act (the Act) authorizes Federal grants to the States for Medicaid programs to provide medical assistance to persons with limited income and resources. While Medicaid programs are administered by the States, they are jointly financed by the Federal and State governments. Each State establishes its own eligibility standards, benefits packages, payment rates, and program administration for Medicaid in accordance with Federal statutory and regulatory requirements. Operating within broad Federal parameters, States select eligibility groups, types, and range of services, payment levels for services, and administrative and operating procedures. Each State Medicaid program must be described and administered in accordance with a Federally-approved “State plan.” This comprehensive document describes the nature and scope of the State's Medicaid program, and provides assurances that it will be administered in conformity with all Federal requirements.</P>
          <P>The Federal government pays its share of medical assistance expenditures to the State on a quarterly basis according to a formula described in sections 1903 and 1905(b) of the Act. Specifically, section 1903 of the Act requires that the Secretary (except as otherwise provided) pay to each State which has a plan approved under title XIX, for each quarter, an amount equal to the Federal medical assistance percentage of the total amount expended during such quarter as medical assistance under the State plan.</P>
          <P>Among the statutory requirements for Medicaid State plans, section 1902(a)(4) of the Act requires that State plans provide for methods of administration as are found to be necessary by the Secretary for the proper and efficient operation of the plan. Section 1902(a)(6) of the Act requires that a State plan for medical assistance provide that the State agency will make such reports, in such form and containing such information, as the Secretary may from time-to-time require, and comply with such provisions as the Secretary may from time-to-time find necessary to assure the correctness and verification of such reports. In addition, section 1902(a)(19) of the Act requires that a State plan for medical assistance provide such safeguards as may be necessary to assure that eligibility for care and services under the plan will be determined, and such care and services will be provided, in a manner consistent with simplicity of administration and the best interests of the recipients.</P>
          <HD SOURCE="HD2">A. The Medicare Program and Quality Improvements Made in the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171)</HD>
          <P>Title XVIII of the Act provides authority for the Secretary to operate the Medicare program, which provides payment for certain medical expenses for persons 65 years of age or older, certain disabled individuals, and persons with end-stage renal disease (ESRD). Medicare benefits include inpatient care, a wide range of medical services, and outpatient prescription drugs.</P>
          <P>The Medicare statute authorizes the Secretary, in the course of operating the Medicare program, to develop, implement, and monitor quality measures, as well as take other actions, to ensure the quality of the care and services received by Medicare beneficiaries.</P>
          <P>Payment under the Medicare program for inpatient hospital services is generally based on the “inpatient prospective payment system” (IPPS) described in section 1886(d) of the Act. Hospitals receive a payment for each inpatient discharge based in part on diagnosis codes that identify a “diagnosis-related group” (MS-DRG). Assignment of an MS-DRG can take into account the presence of secondary diagnoses, and payment levels are also adjusted to account for a number of hospital-specific factors.</P>

          <P>Section 5001(a) of the Deficit Reduction Act of 2005 (Pub. L. 109-171, enacted on February 8, 2006) (DRA) amended section 1886(b)(3)(B) of the Act to expand the set of hospital quality measures collected by Medicare. In particular, this provision directed the Secretary to start collecting baseline measures set forth by the Institute of Medicine in its November 2005 report. In FY 2008 and subsequent years, the Secretary was required to add other measures that reflect consensus among affected parties. The provision also allowed the Secretary to replace and update existing quality measures. The statute mandates that the Secretary establish a process for hospitals to review data that will be made public<PRTPAGE P="32817"/>and, after that process is complete, requires the Secretary to post measures on the Hospital Compare Internet Web site.</P>
          <P>Section 5001(c) of the DRA amended section 1886(d)(4) of the Act to adjust payment to hospitals for certain preventable hospital-acquired conditions (HACs) identified by the Secretary. Specifically, under section 1886(d)(4)(D)(iv) of the Act, the Secretary is required to select codes associated with at least two conditions to be identified as HACs. These conditions are required to have the following characteristics: (a) High cost or high volume or both; (b) result in the assignment of a case to a MS-DRG that has a higher payment when present as a secondary diagnosis; and (c) could reasonably have been prevented through the application of evidence-based guidelines. Section 5001(c) of the DRA provides for revision of the list of conditions from time to time, as long as it contains at least two conditions.</P>
          <HD SOURCE="HD2">B. Previously Specified Medicare HACs</HD>
          <P>Under the provisions of section 1886(d)(4)(D)(ii) of the Act, when a HAC is not present on admission (POA), but is reported as a secondary diagnosis associated with the hospitalization, the Medicare payment under IPPS to the hospital may be reduced to reflect that the condition was hospital-acquired. More specifically, the hospital discharge cannot be assigned to a higher paying MS-DRG if the secondary diagnosis associated with the HAC was the only reason for this assignment.</P>
          <P>Since October 1, 2007, hospitals subject to the IPPS have been required to submit information on Medicare claims specifying whether diagnoses were POA. The POA indicator reporting requirement and the HAC payment provision apply to IPPS hospitals only. This requirement does not apply to hospitals exempt from the IPPS.</P>
          <P>The following is a list of the Medicare HACs for FY 2011 (75 FR 50084 through 50085):</P>
          
          <FP SOURCE="FP-2">• Foreign Object Retained After Surgery.</FP>
          <FP SOURCE="FP-2">• Air Embolism.</FP>
          <FP SOURCE="FP-2">• Blood Incompatibility.</FP>
          <FP SOURCE="FP-2">• Stage III and IV Pressure Ulcers.</FP>
          <FP SOURCE="FP-2">• Falls and Trauma.</FP>
          <FP SOURCE="FP1-2">+ Fractures.</FP>
          <FP SOURCE="FP1-2">+ Dislocations.</FP>
          <FP SOURCE="FP1-2">+ Intracranial Injuries.</FP>
          <FP SOURCE="FP1-2">+ Crushing Injuries.</FP>
          <FP SOURCE="FP1-2">+ Burns.</FP>
          <FP SOURCE="FP1-2">+ Electric Shock.</FP>
          <FP SOURCE="FP-2">• Manifestations of Poor Glycemic Control.</FP>
          <FP SOURCE="FP1-2">+ Diabetic Ketoacidosis.</FP>
          <FP SOURCE="FP1-2">+ Nonketotic Hyperosmolar Coma.</FP>
          <FP SOURCE="FP1-2">+ Hypoglycemic Coma.</FP>
          <FP SOURCE="FP1-2">+ Secondary Diabetes with Ketoacidosis.</FP>
          <FP SOURCE="FP1-2">+ Secondary Diabetes with Hyperosmolarity.</FP>
          <FP SOURCE="FP-2">• Catheter-Associated Urinary Tract Infection (UTI).</FP>
          <FP SOURCE="FP-2">• Vascular Catheter-Associated Infection.</FP>
          <FP SOURCE="FP-2">• Surgical Site Infection Following:</FP>
          <FP SOURCE="FP1-2">+ Coronary Artery Bypass Graft (CABG)—Mediastinitis.</FP>
          <FP SOURCE="FP1-2">+ Bariatric Surgery.</FP>
          <FP SOURCE="FP1-2">—Laparoscopic Gastric Bypass.</FP>
          <FP SOURCE="FP1-2">—Gastroenterostomy.</FP>
          <FP SOURCE="FP1-2">—Laparoscopic Gastric Restrictive Surgery.</FP>
          <FP SOURCE="FP1-2">+ Orthopedic Procedures.</FP>
          <FP SOURCE="FP1-2">—Spine.</FP>
          <FP SOURCE="FP1-2">—Neck.</FP>
          <FP SOURCE="FP1-2">—Shoulder.</FP>
          <FP SOURCE="FP1-2">—Elbow.</FP>
          <FP SOURCE="FP-2">• Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE).</FP>
          <FP SOURCE="FP1-2">+ Total Knee Replacement.</FP>
          <FP SOURCE="FP1-2">+ Hip Replacement.</FP>
          
          <P>The Secretary may revise this list upon review and does so through notice and comment rulemaking.</P>
          
          <HD SOURCE="HD2">C. Previously Specified Medicare National Coverage Determinations (NCD)</HD>
          <P>In 2002, the National Quality Forum (NQF) published “Serious Reportable Events in Healthcare: A Consensus Report”, which listed 27 adverse events that were “serious, largely preventable and of concern to both the public and health care providers.” These events and subsequent revisions to the list became known as “never events.” This concept and need for the proposed reporting led to NQF's “Consensus Standards Maintenance Committee on Serious Reportable Events,” which maintains and updates the list which currently contains 29 items.</P>
          <P>The Medicare program has addressed certain “never events” through national coverage determinations (NCDs). Similar to any other patient population, Medicare beneficiaries may experience serious injury and/or death if they undergo erroneous surgical or other invasive procedures and may require additional healthcare to correct adverse outcomes that may result from such errors. To address and reduce the occurrence of these surgeries, CMS issued three NCDs. Under these NCDs, CMS does not cover a particular surgical or other invasive procedure to treat a particular medical condition when the practitioner erroneously performs: (1) A different procedure altogether; (2) the correct procedure but on the wrong body part; or (3) the correct procedure but on the wrong patient. Medicare will also not cover hospitalizations and other services related to these non-covered procedures.</P>
          <HD SOURCE="HD2">D. Prior Guidance on Medicaid HACs and NCDs in Response to Medicare's Policy</HD>
          <P>Section 5001(c) of the DRA addressed only payment under the Medicare IPPS and did not require that Medicaid implement nonpayment policies for HACs. However, in light of the Medicare requirements, we encouraged States to adopt payment prohibitions on provider claims for HACs to coordinate with the Medicare prohibitions under section 1886(d)(4)(D) of the Act. To accomplish this task, we issued State Medicaid Director Letter (SMDL) #08-004 on July 31, 2008. In the July 31, 2008 SMDL, we noted that there was variation in how State Medicaid programs had addressed such claims in the past. The letter noted that nearly 20 States already had, or were considering, eliminating payment for some or all of the 28 conditions on the NQF's list of Serious Reported Events. Other States had more limited efforts to deny payment for services related to such conditions because the services were “medically unnecessary” in light of the primary diagnosis.</P>
          <P>Recognizing this variation and addressing the immediate concern of the States over Federal cost-shifting that could result from the Medicare HAC policy as applied to those who are dually-eligible for Medicare and Medicaid, we took a flexible position in the July 31, 2008 SMDL guidance on State Medicaid handling of the issue. The SMDL indicated that States seeking to implement HAC nonpayment policies could do so by amending their Medicaid State plans to specify the extent to which they would deny payment for an HAC. Those interested only in avoiding secondary liability for Federal Medicare denials of HACs and NCDs in the case of dual-eligibles could do so by amending their State Plan to indicate that payment would not be available for HACs and the procedures described in the three NCDs that are not paid by Medicare. States that wanted broader payment prohibitions could indicate that payment would not be available for conditions specified in the State plan amendment (SPA), or that meet criteria identified in the SPA.</P>
          <HD SOURCE="HD2">E. Section 2702 of the Affordable Care Act</HD>

          <P>Section 2702 of the Affordable Care Act requires that the Secretary implement Medicaid payment adjustments for health care-acquired conditions (HCACs). Section 2702 of the<PRTPAGE P="32818"/>Affordable Care Act did not grant the Secretary new authorities, indicating that existing statutory authorities are sufficient to fulfill the obligation. Section 2702(a) of the Affordable Care Act sets out a general framework for application of Medicare prohibitions on payment for HCACs to the Medicaid program. Section 2702(a) of the Affordable Care Act first directs the Secretary to identify current State practices that prohibit payment for HCACs and to incorporate the practices identified, or elements of such practices, which the Secretary determines appropriate for application to the Medicaid program in regulations. Section 2702(a) of the Affordable Care Act then requires that, effective as of July 1, 2011, the Secretary prohibit payments to States under section 1903 of the Act for any amounts expended for providing medical assistance for HCACs specified in regulations. Such regulations must ensure that the prohibition on payment for HCACs shall not result in a loss of access to care or services for Medicaid beneficiaries.</P>
          <P>Section 2702(b) of the Affordable Care Act defines the term “health care-acquired condition” as “a medical condition for which an individual was diagnosed that could be identified by a secondary diagnostic code described in section 1886(d)(4)(D)(iv) of the Act.”</P>
          <P>Section 2702(c) of the Affordable Care Act specifically requires that the Secretary, in carrying out section 2702 of the Affordable Care Act, apply the regulations issued under section 1886(d)(4)(D) of the Act relating to the prohibition of payments based on the presence of a secondary diagnosis code specified by the Secretary in such regulations, as appropriate for the Medicaid program. The Secretary may exclude certain conditions identified under title XVIII of the Act for nonpayment under title XIX of the Act when the Secretary finds the inclusion of such conditions to be inapplicable to beneficiaries under title XIX of the Act.</P>
          <P>We believe, and confirmed through public comment, that incorporating Medicare's HACs in Medicaid's policy is inherently complex because of population differences across programs. We fully understand that the HACs developed for Medicare's population will not directly apply to various subsets of Medicaid's population. While we have established Medicare as a baseline, we understand that States will, through their payment policies, appropriately address these differences.</P>
          <HD SOURCE="HD2">F. Requirement To Review Existing State Practices Prohibiting Nonpayment Policies for HCACs</HD>
          <P>Section 2702 of the Affordable Care Act requires that the Secretary identify current State practices that prohibit payment for HCACs and incorporate those practices, as appropriate, into Medicaid regulations.</P>
          <P>To fulfill the statutory direction, we reviewed existing SPAs originally submitted in response to the July 31, 2008 SMDL (#08-004). We also researched State HCAC-related nonpayment policies that had been implemented outside of Medicaid State plans. We reviewed State quality assurance programs, pay-for-performance programs, reporting requirements and procedures, and payment systems.</P>
          <P>We reviewed various articles, reports, summaries, and data bases pertaining to States' existing practices concerning hospital and HCACs and infections. For a list of the items considered, see the February 17, 2011 proposed rule (76 FR 9283, 9286 through 9287).</P>
          <P>We discussed internally within CMS, as well as with interagency partners at the Agency for Healthcare Research and Quality (AHRQ) and the CDC to ensure that the proposed regulations were consistent with other regulations, policies, and procedures currently in existence surrounding this issue. We also met with them to gain information on areas where we could mirror existing processes to eliminate undue burdens on States or providers.</P>
          <P>We issued a State survey to capture data from all related payment policies regardless of whether they were implemented as a result of the July 31, 2008 SMDL or whether such practices are currently detailed in the State plan. We have received helpful information from a few States through the survey and have reviewed other information that has been helpful in explaining current State processes for making payment adjustments for HCACs. Subsequent to the publication of the survey, we held all-State calls where we answered questions in response to the survey, had States with existing policies talk about their experiences, and listened to discussion regarding the implementation of the HCAC policy.</P>
          <P>We met with nongovernmental partners including the NQF, the National Academy for State Health Policy, the National Association of Children's Hospitals, the Joint Commission, and State Medicaid Medical Directors. Most of these organizations are primarily focused on State program development and/or quality issues. We reached out to them to ensure that the proposed policies were consistent with current industry understanding of both State payment and quality improvement goals. In our discussions with these organizations, we were able to discuss State experiences on a broad, national level that had been gained from working with States. During these meetings, we discussed a number of issues related to the proposed rule and State concerns in implementing this provision. For instance, it was clear from many of our discussions that States hoped to be able to look to this provision to provide additional definition regarding the types of conditions to identify for nonpayment, as well as to provide some support in working with provider communities to which these policies would be applied.</P>
          <HD SOURCE="HD2">G. Current State Practices Prohibiting Payment for HACs, HCACs, and Other Similar Events</HD>
          <P>We found that 29 States do not have existing HCAC-related nonpayment policies. Most of the 21 States that currently have HCAC-related nonpayment policies identify at least Medicare's HACs for nonpayment in hospitals. However, it is important to note that at least half of the existing policies we reviewed exceeded Medicare's current HAC requirements and policies, either in the conditions identified, the systems used to indicate the conditions, or the settings to which the nonpayment policies applied. These policies vary tremendously from State to State in the authority used to enact the policies, the terminology used, the conditions identified, State's utilization of the current Medicare HAC list, the service settings to which nonpayment policies are applied, reporting requirements, and the claims processing of the nonpayment policies.</P>
          <P>All of the States with HCAC-related nonpayment policies have implemented provisions that would protect the State from dual-eligible liability either by directly prohibiting payment for Medicare crossover claims or by relying on existing State plan authority to deny payment for claims previously denied by Medicare.</P>

          <P>We found that 17 of the States implemented Medicaid specific policies that reduce payment for services provided to Medicaid beneficiaries. Most of the States implementing Medicaid specific policies identify at least Medicare's current list of HACs, and nearly half of those States defined a list that was different from Medicare's current list of HACs for nonpayment.<PRTPAGE P="32819"/>
          </P>
          <P>Similar variation exists in States' plan language identifying Medicare's NCD for nonpayment ranging from mirroring Medicare to completely breaking from Medicare. We do note, however, that the nature of the NQF serious reportable events, like surgery on the wrong body part, proper surgery wrong patient, and wrong surgery, is so severe that States were likely to have relied on State coverage provisions and appropriate care requirements to deny payment for these events.</P>
          <P>We also found that States use different general terminology for HCAC-related nonpayment policies even though many of the conditions identified overlap, are from the same sources, and do not generally vary in medical definition from one list to the other. For example, 3 States identify “air embolism” as a condition for nonpayment under its plans with the condition understood to be consistently defined for medical purposes. However, one State includes air embolisms on its list of “HACs”; another includes the same condition as a “Serious Adverse Event”; and the third includes it on a list of “Medical Errors.”</P>
          <P>We also found that at least 7 of the States with HCAC-related nonpayment policies apply those policies to settings other than the inpatient hospital setting required by Medicare, including both physicians and ambulatory surgical centers.</P>
          <P>Variation across States is not surprising given the States have been permitted broad flexibility in defining their HCAC policies and programs. However, we attribute some of the variety on this issue to the wealth of information and evidence-based guidelines available to States, either through their own experiences and resources or through industry researched and developed resources related to health system quality. Data gathered on the conditions identified, reporting strategies, and implementation guidelines indicate that States have relied heavily on existing health system quality improvement research to define requirements while tailoring policies appropriate to their own systems. In addition, our research indicates that States' HCAC-related nonpayment policies are mainly intended to drive broader health system agendas to promote quality outcomes. We believe the use of evidence-based measures and the push for health system quality are an appropriate foundation for the proposed regulation. We proposed to implement Medicaid HCAC regulations that would provide some consistency across health care payers (Medicare and Medicaid). At the same time, we also proposed to accommodate State flexibility to design individual HCAC policies for nonpayment, quality-related programs suitable for their own Medicaid program and health marketplace to the extent such policies go beyond Federally-established minimum standards. The July 31, 2008 SMDL (#08-004) instructed States to submit SPAs to enact nonpayment provisions. Thirteen States submitted SPAs to include PPC related nonpayment provisions in their Medicaid State plans. Other States that implemented these policies through some other authority like State law or administrative procedures will be required to submit new SPAs for review and work with CMS to ensure their policies, effective July 1, 2011, are in line with the final provisions of this rule.</P>
          <HD SOURCE="HD2">H. Provider Preventable Conditions</HD>
          <P>The final rule includes the umbrella term, “Provider-Preventable Conditions (PPC)” which is defined as two distinct categories, Health Care-Acquired Conditions (HCAC) and Other Provider-Preventable Conditions (OPPC).</P>
          <P>Health Care Acquired Conditions:</P>
          <P>• Apply to Medicaid inpatient hospital settings; and</P>
          <P>• Are defined as the full list of Medicare's HAC, with the exception of Deep Vein Thrombosis/Pulmonary Embolism following total knee replacement or hip replacement in pediatric and obstetric patients, as the minimum requirements for States' PPC non-payment programs.</P>
          <P>Other Provider-Preventable Conditions include the following:</P>
          <P>• Apply broadly to Medicaid inpatient and outpatient health care settings where these events may occur;</P>
          <P>• Are defined to include at a minimum, the three Medicare National Coverage Determinations (surgery on the wrong patient, wrong surgery on a patient, and wrong site surgery);</P>
          <P>• Would allow States to expand to settings other than IH with CMS approval by nature of identifying events that occur in other settings; and</P>
          <P>• Would allow States to expand the conditions identified for non-payment with CMS approval, based on criteria set forth in the regulation.</P>
          <P>The final rule requires that States revise Medicaid plans to comply with this provision and mandates that States implement provider self reporting through claims systems. The final rule protects beneficiary access to care by eliminating States' ability to unduly impact providers for the occurrence of conditions identified. The final rule requires that:</P>
          <P>• No reduction in payment for a provider preventable condition will be imposed on a provider when the condition defined as a PPC for a particular patient existed prior to the initiation of treatment for that patient by that provider.</P>
          <P>• Reductions in provider payment may be limited to the extent that the identified provider-preventable conditions would otherwise result in an increase in payment; and the State can reasonably isolate for nonpayment the portion of the payment directly related to treatment for, and related to, the provider-preventable conditions.</P>
          <P>While the Statutory effective date is July 1, 2011, CMS intends to delay compliance action on these provisions until July 1, 2012.</P>
          <P>We proposed to exercise our authority under sections 1902(a)(4), 1902(a)(19), and 1902(a)(30)(A) of the Act to provide for identification of provider preventable conditions (PPCs) as an umbrella term for hospital and nonhospital acquired conditions identified by the State for nonpayment to ensure the high quality of Medicaid services. These statutory provisions authorize requirements that States use methods and procedures determined by the Secretary to be necessary for the proper and efficient administration of the State plan, to provide care and services in the best interests of beneficiaries, and to provide for payment that is consistent with quality of care, efficiency, and economy.</P>
          <P>With the introduction of this term, we proposed to include two categories of PPCs—HCACs and other provider-preventable conditions (OPPCs). HCACs would apply as required under the statute. OPPCs would be applicable to other conditions that States identify and have approved through their Medicaid State plans.</P>
          <P>The inclusion of the new terms, PPCs and OPPCs, is consistent with the implementation of a broader application of this policy which allows us to appropriately incorporate existing State practices. The adoption of a new term is necessary because the term, “health care-acquired condition” is very narrowly defined in the Statute and does not provide for the inclusion of conditions other than those identified as HACs for Medicare, even excludes the three Medicare NCDs. Additionally, the Affordable Care Act definition of HCACs only applies to the inpatient hospital setting.</P>

          <P>We considered a broader definition of the term, “health care-acquired conditions,” attempting to isolate the idea of the actual condition from the setting in which it occurred. Section<PRTPAGE P="32820"/>1886(d)(4)(D)(iv) of the Act applies specifically to conditions applicable to inpatient hospital patients and reimbursed under the IPPS. We did look to the Affordable Care Act in creating the terms PPCs and OPPCs.</P>
          <P>We did look to the Affordable Care Act in creating the terms PPC and OPPC. Section 3008(b) of the Affordable Care Act, “Study And Report On Expansion Of Healthcare Acquired Conditions Policy To Other Providers,” requires that Medicare study the effects of expanding its existing policy to other providers. We adopted the “Other Providers” term to remain consistent with Medicare in the potential expansion of its policy.</P>
          <P>In looking to expand the overall policy, we considered a number of other terms but determined that many of them like “adverse events” or “serious reportable events” would generate confusion because they had existing industry definitions that did not necessarily overlap with our policy aims. We adopted the term “Provider Preventable Condition” for use in Medicaid because it appropriately identified the scope of the conditions and could act as a “catch-all.” Also, the term had not been narrowly defined by use in Medicare, Medicaid, or in the industry at-large.</P>
          <HD SOURCE="HD2">I. Reporting of Results</HD>
          <P>After researching State, industry, and Federal information related to the importance of reporting of quality data in driving improved health outcomes, we proposed that a simplified level of reporting is essential to creating a successful nonpayment policy both from the payment and quality perspectives. We believe that any requirements for provider reporting should provide a consistent format for States to report State-specific measures; require that providers report conditions identified for nonpayment when they occur regardless of a provider's intention to bill; and not cause undue burden on States or providers.</P>
          <P>Quality reporting related to PPCs across States is inconsistent. There are 27 States that require reporting of either hospital-acquired infections, conditions, or some combination of both. Some of those States require quality reporting but have not implemented associated HCAC-related nonpayment policies. Others have HCAC-related nonpayment policies, but have not implemented quality reporting requirements.</P>
          <P>Existing national quality reporting formats do not support the collection of data on HCACs and OPPCs for Medicaid beneficiaries. Providers, mainly hospitals, are subject to reporting requirements in addition to those imposed by States. For instance, most hospitals report some quality measures to CMS, the Joint Commission, or the CDC. We considered requiring hospitals to report to CMS or the National Health Safety Network, but decided against this because of concerns about the capacity within these systems to accommodate State specific reporting of varied measures and the fact that this might not be consistent with what most States are currently requiring providers to report.</P>
          <P>HACs, HCACs, and related policies represent liabilities for providers beyond nonpayment provisions. In fact, Medicare and the industry-at-large, have experienced nonclaiming or nonbilling on the part of providers seeking to escape the liability that could come with any type of notification of a particular event or to avoid negative health outcome indicators.</P>
          <P>In consideration of our research, we proposed a requirement that existing claims systems be used as a platform for provider self-reporting. We also proposed to include reporting provisions that would require provider reporting in instances when there is no associated bill. For instance, States could employ the widely used POA system in combination with including edits in their Medicaid claims systems that would indicate an associated claim and flag it for medical review.</P>
          <HD SOURCE="HD2">J. States’ Use of Payment Systems Other Than MS-DRG</HD>
          <P>We also found that States' payment systems will dictate the manner in which States are able to operationalize PPCs related nonpayment policies. For instance, some States reimburse using MS-DRG or some other type of grouper software to price claims. As with Medicare, these States may use the POA indicator system to identify claims and reduce payments by programming the grouper to reduce payment through the grouper. We note that a considerable number of States do not use grouper systems to reimburse providers. These States may identify and reduce payment for HCACs using methods appropriate to the specific reimbursement system used within that State. We believe that the proposed provision allows States this type of flexibility in designing methodologies that would isolate amounts for nonpayment and allow provider payment to be reduced based on a CMS-approved State plan methodology that is prospective in nature.</P>
          <HD SOURCE="HD1">II. Summary of the Provisions of the Proposed Rule and Analysis of and Responses to Public Comments</HD>
          <HD SOURCE="HD2">A. General Discussion</HD>
          <P>We proposed to codify provisions that would allow States flexibility in identifying PPCs that include, at a minimum, the HACs identified by Medicare, but may also include other State-identified conditions. This flexibility will extend to applying nonpayment provisions to service settings beyond the inpatient hospital setting. We believe that establishing Medicare as the minimum for the application of this policy is appropriate at this point.</P>
          <P>We encouraged States to consider the benefits and quality implications of expanding HCAC quality and nonpayment policies as more information becomes available from Medicare and State Medicaid programs.</P>
          <P>We proposed that PPCs are defined under two categories: HCACs and OPPCs. We proposed to define the category of PPCs that would be referred to using the term “health care-acquired conditions” (HCACs) based on the definition of that term in section 2702(b) of the Affordable Care Act. We also noted that the Secretary has authority to update the Medicare HAC list as appropriate. As such, States are required to comply with subsequent updates or revisions in accordance with section 1886(d)(4)(D) of the Act.</P>
          <P>We proposed to require that States implement requirements for provider self-reporting of HCACs in the Medicaid claims payment process. We also proposed to provide that States may identify similar OPPCs related to services furnished in settings other than inpatient hospitals, which would also be subject to a payment prohibition.</P>
          <P>We further proposed that the treatment of these OPPCs will be similar to the treatment of HCACs. State plans must provide for nonpayment for care and services related to these OPPCs, and Federal financial participation (FFP) will not be available in State expenditures for such care and services related to OPPCs.</P>
          <P>We received the following comments in response to our general discussion.</P>
          <HD SOURCE="HD3">1. General Comments</HD>
          <P>
            <E T="03">Comment:</E>One commenter expressed the view that the original Medicare HAC policy adopted by CMS in FY 2008 for hospitals subject to the Medicare Inpatient Prospective Payment System (IPPS hospitals), in response to the requirements of the DRA, was flawed policy and that many physicians disagreed with the notion that some of<PRTPAGE P="32821"/>the identified Medicare HACs are reasonably preventable. The commenter was opposed to extending these provisions to Medicaid and suggested that CMS abandon the notion of a nonpayment policy for HACs in both Medicare and Medicaid and replace it with a policy encouraging compliance with evidence-based guidelines.</P>
          <P>
            <E T="03">Response:</E>We disagree. The Medicare HAC payment policy was established under the authority of section 5001(c) of the DRA and has been in place since FY 2008. Section 2702 of the Affordable Care Act requires that CMS adopt similar regulations for the Medicaid program taking into consideration existing State practices and the appropriate application to the Medicaid program. This regulation, like the Medicare HAC rule that preceded it, was developed in direct response to the enactment of that provision. While we recognize that some of the PPCs are not entirely preventable and should therefore be excluded from the program. However, most of these PPCs are never events, which means they should never happen, in the first place, and they are entirely preventable if providers follow best medical practices. This is true regardless of whether a patient is a senior citizen on Medicare or a child on Medicaid. PPCs that used to be regarded as not entirely preventable, like CLABSI (or CAUTI), have been shown to be preventable by providers. We believe that the provisions of this rule will provide a strong incentive for the provider to apply best medical practice and seek innovative methods to prevent adverse outcomes. The HACs were adopted by Medicare through an evidence-based process. In addition, the definition used for OPPC in new § 447.26 provides that States must consider evidence-based guidelines in adopting optional PPCs.</P>
          <P>
            <E T="03">Comment:</E>Some commenters supported the policy of payment adjustment when conditions were demonstrated to be reasonably preventable based on the evidence, but thought that the population differences between Medicare and Medicaid may present distinct issues and considerations in considering events for nonpayment. Some commenters questioned the appropriateness of the application of Medicare HACs to Medicaid populations, specifically children and pregnant women.</P>
          <P>
            <E T="03">Response:</E>We agree that Medicare's population is generally different than Medicaid's and that those differences may present distinct issues and considerations. We realize that some categories of Medicare's HACs, like Surgical Site Infection following CABG or Bariatric surgery, are not typically applicable to pediatric or obstetric populations because the underlying conditions associated with each of Medicare's HACs will not typically occur in those populations, thus limiting the frequency and relevance of the HAC. We reviewed each of Medicare's HACs and the related evidence-based prevention protocols to determine whether the final rule should specifically exclude any of the conditions identified by Medicare, with respect to populations more characteristic of Medicaid, particularly children and pregnant women. We considered each in relation to the following:</P>
          <P>(1)<E T="03">Clinical applicability.</E>That is, does this condition occur in pediatric and obstetric populations enough to significantly impact the populations or provider reimbursement?</P>
          <P>(2)<E T="03">Availability of evidence based guidelines appropriate to prevention for the pediatric and obstetric populations.</E>Are there bundles specific to preventing these conditions and infections in the pediatric and obstetric populations? If bundles do not exist, are there other bundles that can be appropriately applied to these populations?</P>
          <P>(3)<E T="03">Reasonable preventability.</E>Can the conditions or infections be reasonably prevented through the use of evidence based guidelines to warrant financial penalties? Our research determined that certain Medicare HACs, such as Foreign Objects Retained After Surgery, Air Embolism, Blood Incompatibility, Stage 3 and 4 Pressure Ulcers, Falls and Trauma, and Manifestations of Poor Glycemic Control, Catheter Associated Urinary Tract Infections, and Vascular-Catheter Associated Blood Stream Infections, are clinically applicable to all Medicaid populations, including children and pregnant women. We determined that there are evidence-based guidelines to support the reasonable preventability of these conditions in pediatric and obstetric populations, and that there is no indication that these prevention guidelines would cause harm if appropriately applied. There was no evidence to indicate that a provider adhering to these evidence based guidelines could not reasonably prevent, though not absolutely prevent these infections in every case in Medicaid populations.</P>
          <P>Our research determined that Surgical Site Infection following CABG, Bariatric Surgery, or Orthopedic procedures is not typically applicable to children and pregnant women because it is not likely that these populations would be subject to some of the primary surgical procedures. However, we determined that there are evidence-based guidelines to support the reasonable preventability of Surgical Site Infection following the specified procedures when they do occur in these populations. Furthermore, there is no indication that these prevention guidelines would cause harm when appropriately applied. There is no evidence to indicate that a provider adhering to these evidence based guidelines could not reasonably prevent, though not absolutely prevent, these infections in every case in Medicaid populations.</P>
          <P>Our research also determined that the Medicare HAC Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) as related to a total knee replacement or hip replacement is not a common occurrence for children or pregnant women because it is not likely that these populations would be subject to the primary surgical procedures of total knee replacement or hip replacement. We determined that evidence-based guidelines available support the reasonable preventability of DVT/PE in most cases, however, the related prevention protocols have not been proven appropriate for application in children and pregnant women. Therefore, we are not identifying the Medicare HAC, DVT/PE as related to total knee replacement, or hip replacement for pediatric or obstetric populations under Medicaid's PPC policy. We have revised the final rule to reflect this determination.</P>
          <P>We remind commenters that the Medicare HACs serve as a baseline, and that States electing to expand their policies to consider other conditions associated with children and pediatric quality measures may do so through the SPA process. We encourage States to collaborate both with CMS and other States, as well as their provider communities and stakeholders like CDC and AHRQ to implement informed policies appropriate to their Medicaid populations. We will support State efforts and cross-educate, through the State plan amendment process and by providing information that we gather from States and other programs.</P>
          <P>
            <E T="03">Comment:</E>One commenter believed that the expansion of PPCs for Medicaid under the proposed rule goes beyond any previous guidance shared by CMS with the State during Affordable Care Act-related conference calls.</P>
          <P>
            <E T="03">Response:</E>Discussions held with the States, stakeholder groups and various provider communities regarding this policy were necessary to determine existing State practices regarding non-payment for health care-acquired conditions. They were informational for<PRTPAGE P="32822"/>CMS and did not in any way commit the Secretary to a particular policy direction. They were also a first effort in allowing States without existing policies to gather some general information from and network with States with existing policies.</P>
          <P>The final regulation incorporates conditions identified as Medicare's HACs, with the exception of DVT/PE as related to total knee replacement and total hip replacement for pediatric and obstetric populations, and 3 NCDs as the minimum requirement for State PPC nonpayment policies. The rule allows States the flexibility, if desired, but does not require, States to identify additional conditions as PPCs under their Medicaid programs. Additionally, States have already begun to develop PPC-related non-payment policies and this rule would allow that work to continue.</P>
          <P>
            <E T="03">Comment:</E>A few commenters believed that there was not sufficient time to implement these provisions for providers that had not already been subject to Medicare's policy, and were particularly concerned with the implementation timeframes for reporting.</P>
          <P>
            <E T="03">Response:</E>We anticipate that States and providers, especially those groups of providers that have not been subject to Medicare's HAC policy, will need to work collaboratively to develop policies and implement reporting systems that would complement existing payment structures. We believe given the timeframes involved and the need for States to provide guidance to providers, it would be appropriate to delay compliance action on the provisions of the rule until July 1, 2012.</P>
          <P>
            <E T="03">Comment:</E>One commenter requested that we strike § 447.26(c)(4) because they believed the access requirements proposed there were already reflected in 447.204 which requires that payment be sufficient to assure beneficiary access. The commenter thought that any dual interpretations could lead to unwarranted litigation risks.</P>
          <P>
            <E T="03">Response:</E>We thank the commenter for this comment. We have revised the language at 447.26(c)(4) to clarify that, “A State plan must ensure that non-payment for provider-preventable conditions does not prevent access to services for Medicaid beneficiaries.”</P>
          <HD SOURCE="HD3">2. Conditions Identified and Providers Affected</HD>
          <P>
            <E T="03">Comment:</E>Some commenters pointed out that Medicare's HAC policy applies only to Medicare IPPS hospitals. These commenters believed that CMS should limit Medicaid PPC payment restrictions to Medicaid participating hospitals that are similar to Medicare IPPS hospitals. Other commenters asked for clarification on this same point. Most of these commenters also believed that we should limit States ability to identify other PPCs, proposing that the set of Medicare's HACs and 3 NCDs be used as a ceiling instead of as a floor for Medicaid's PPC policy.</P>
          <P>
            <E T="03">Response:</E>The Affordable Care Act requires that HACs identified under the Medicare IPPS are applicable to all entities that operate as Medicaid inpatient hospitals. We do not have the authority to exempt any Medicaid inpatient hospital providers from these requirements. States currently have the authority to extend PPC-related non-payment policies to other conditions.</P>
          <P>
            <E T="03">Comment:</E>Some commenters objected to the entire category of OPPC (affecting providers other than hospitals) included in the proposed regulation. Commenters recommended that CMS consider and impose a number of parameters related to States' implementation and selection of the OPPC category.</P>
          <P>
            <E T="03">Response:</E>In preparing this regulation, the Statute required that CMS consider existing State practices and determine whether, as a matter of policy, it was appropriate to include those established practices in these final regulations. We determined that, in some instances, States had implemented provisions that applied to providers in settings other than inpatient hospital settings, including outpatient hospital settings. We did not believe that it was prudent to require of all States what had been done in a few, but we wanted to provide States the flexibility to do so. Accordingly, we designed the PPC provisions to allow the expansion of State policies to other care settings, and other conditions. In light of the differences between the types of participating providers and the enrollee populations in Medicare and Medicaid, we provided flexibility for States in the identification and application of OPPCs. We anticipate that States will consider arguments made by particular providers that these OPPCs should be defined so that they do not apply to them. We believe this is the appropriate forum for consideration of the unique circumstances of particular providers.</P>
          <P>
            <E T="03">Comment:</E>Some commenters recommended that we consider the benefits of and establish a nationally consistent set of conditions identifiable as PPCs for Medicaid.</P>
          <P>
            <E T="03">Response:</E>We determined that the conditions identified as Medicare's HACs, with the exception of DVT/PE as related to total knee replacement and total hip replacement for pediatric and obstetric populations, and 3 NCDs are appropriate to serve as the baseline for Medicaid's PPC policy. We are strongly committed to permitting State flexibility to innovate in this area. State innovation has been a significant driver of Federal policy, and States have direct experience with utilization and claims review with respect to Medicaid services.</P>
          <P>
            <E T="03">Comment:</E>Some commenters suggested that the initial set of conditions be more limited and targeted, and that they be expanded incrementally over time.</P>
          <P>
            <E T="03">Response:</E>Section 2702(b) of the Affordable Care Act defines the term “health care-acquired condition” as “a medical condition for which an individual was diagnosed that could be identified by a secondary diagnostic code described in section 1886(d)(4)(D)(iv) of the Act.” The provision also allows the Secretary to exclude conditions not appropriate for application in Medicaid. As such, the final regulation incorporates conditions identified as Medicare's HACs, with the exception of DVT/PE as related to total knee replacement and total hip replacement for pediatric and obstetric populations, and 3 NCDs. Additionally, we believe that the flexibility provided States in developing additional PPCs, beyond those established as the floor in the final rule, allow for the type of incremental expansion of this policy that the commenters suggest.</P>
          <P>
            <E T="03">Comment:</E>Other commenters recommended that Medicaid PPCs focus on conditions specific to the Medicaid population. A few commenters offered that it would be ideal for CMS to evaluate other Medicaid specific conditions that would apply specifically to pregnant women or children.</P>
          <P>
            <E T="03">Response:</E>We believe that the flexibility provided States in the final rule will facilitate the development of additional Medicaid specific conditions to be identified for nonpayment. Some State Medicaid programs with existing policies have identified conditions specific to certain populations like Obstetrical Hemorrhage with Transfusion, which is a condition specific to pregnant women. We encourage States to follow CMS's example in identifying conditions by working with provider communities and industry partners.</P>
          <P>
            <E T="03">Comment:</E>A few commenters suggested that CMS coordinate Federal PPCs policies across agencies and with other organizations developing quality measures specific to Medicaid populations.</P>
          <P>
            <E T="03">Response:</E>We are actively working to coordinate with other health reform initiatives such as the pediatric core quality measures, accountable care<PRTPAGE P="32823"/>organizations, and health insurance exchanges to develop coordinated Federal policy in the area of Health System Quality. We continue to collaborate with States, providers, and other stakeholders to inform policy decisions related to this area.</P>
          <P>
            <E T="03">Comment:</E>Some commenters stated that any extension of PPC beyond the hospital setting was premature, and emphasized that application of PPC to other providers was not feasible because of the different patient populations, payment structures and conditions that applied in different environments. These commenters stated unique issues in various provider settings including long-term care settings, dialysis clinics, and skilled nursing facilities.</P>
          <P>
            <E T="03">Response:</E>We disagree with the point that the PPC provisions should be limited to the hospital environment. This rule requires that States adopt minimum requirements for each category of PPC. States have the flexibility to identify additional OPPCs if desired, but there is no requirement to do so. Many States have already identified conditions beyond the minimum requirements in this final rule. We understand clearly that the category of OPPCs would allow expansion beyond the hospital environment and must be done in close consultation with affected providers and limited to situations where a State has made a finding that the condition could reasonably have been prevented in ordinary cases. We have revised regulatory text to make clear that these are State determinations that must be made based on State findings that the condition is reasonably preventable using procedures supported by evidence-based guidelines. The identification of PPCs in settings other than the hospital setting makes sense because, from the perspective of the patient, it matters very little whether a wrong site surgery occurred in a hospital, an ambulatory surgery center, or in a minor surgery done in the physician's office. Moreover, States have already gone beyond the hospital setting in their individual PPC policies. All that this Federal regulation adds is the HCAC category which requires nonpayment for the full list of Medicare's HACs, with the exception of Deep Vein Thrombosis/Pulmonary Embolism following total knee replacement or hip replacement in pediatric and obstetric patients and the OPPC category which requires the minimum mandatory inclusion of what are now the three Medicare NCDs: Surgery on the wrong patient, wrong surgery on a patient, and wrong site surgery. We are simply replicating the mandatory provisions in the Medicare program, and adding these to the existing State flexibility under Medicaid to establish payment and quality standards.</P>
          <P>We encourage States to collaborate both with CMS and other States, as well as their provider communities and stakeholders like CDC and AHRQ to implement informed policies appropriate to their Medicaid populations. We will support State efforts and cross-educate, through the SPA process and by providing information that we gather from States and other programs.</P>
          <P>
            <E T="03">Comment:</E>A number of commenters requested that CMS clarify that the HCAC category applies only to inpatient hospitals.</P>
          <P>
            <E T="03">Response:</E>This final rule has revised regulatory language to clarify that the HCAC category applies to all inpatient hospital settings under Medicaid. The OPPC category minimum requirements (Medicare's 3 NCDs) are applicable in any healthcare service setting where these events may occur.</P>
          <P>
            <E T="03">Comment:</E>One commenter expressed concern that expansion of PPC to nonhospital providers threatened the access of Medicaid beneficiaries to care. In particular, the commenter asked CMS to clarify that Medicaid payment disallowance for PPC would not apply when the PPC was present at the time the provider commenced treatment of the patient.</P>
          <P>
            <E T="03">Response:</E>The language in the proposed regulation was intended to cover only situations where payment reduction was being applied to treatment for a condition not present on admission or commencement of treatment by that provider. However, we understand that clarifying the language of the regulation to emphasize this point would be helpful and have done so in this final regulation. New § 447.26 (c)(2) explicitly states that “* * * no reduction in payment for a PPC will be imposed on a provider when the condition defined as a PPC for a particular patient existed prior to the initiation of treatment for that patient by that provider.” This was implied in the previous language, but has now been made explicit. CMS agrees with the comment and is providing this clarification.</P>
          <P>CMS disagrees with the commenter's point that the expansion of State PPC policies beyond the hospital environment will limit access. We understand clearly that expansion beyond the hospital environment must be done in close consultation with affected providers and limited to situations where a provider could reasonably have prevented the PPC. However, from the perspective of the patient, it matters very little whether a wrong site surgery occurred in a hospital, an ambulatory surgery center, or in a minor surgery done in the physician's office. Moreover, as the commenter notes, States have already gone beyond the hospital setting in their individual PPC policies.</P>
          <P>
            <E T="03">Comment:</E>One commenter requested that CMS provide States additional guidance on applying the Medicare HAC criteria to Medicaid providers and conditions. This commenter believed that we should partner with States to have continued dialogue on evidence-based guidelines.</P>
          <P>
            <E T="03">Response:</E>As stated throughout the rule, we intend to continue dialogue with States and other Agencies related to this issue.</P>
          <HD SOURCE="HD3">3. PPC Terminology</HD>
          <P>
            <E T="03">Comment:</E>A few commenters believed that the distinctions among the terms in the proposed rule were confusing and made it difficult to understand which term applied to which criteria.</P>
          <P>
            <E T="03">Response:</E>We have revised the regulatory text to clarify that PPCs are clearly defined into two separate categories, HCACs (conditions identified as Medicare's HACs (with the exception of DVT/PE following total knee replacement or hip replacement in pediatric and obstetric patients) for IPPS purposes, applied broadly to Medicaid inpatient hospitals) and OPPCs (conditions applicable in any healthcare service setting minimally defined as Medicare's 3 NCDs).</P>
          <P>
            <E T="03">Comment:</E>A few commenters objected to the use of the term PPC. One proposed the use of the alternative term “Preventable Healthcare Related Conditions.” The commenters noted that one proprietary organization is currently utilizing the acronym PPC for “Potentially Preventable Conditions.”</P>
          <P>The commenters also questioned our use of the term other provider preventable condition and stated their biggest concern was with creating a new term that encompassed 3 NCDs so closely related with the NQF's “Serious Reportable Events in Healthcare.” The commenters recommended that CMS not create explicit category titles under the PPC umbrella term.</P>
          <P>
            <E T="03">Response:</E>As stated in the preamble, the designation of these terms is necessary to a policy that meets statutory requirements in setting Medicare's policy as the minimum and allowing States the flexibility to expand beyond that minimum. We do not believe that the term PPC has been<PRTPAGE P="32824"/>narrowly defined across the industry to include a specific set of policy provisions as would be required by this final rule. In addition, we do not believe that the use of the PPC acronym will infringe on any proprietary organizations' ability to continue to use that acronym. We have not made any revisions to this final rule to reflect this comment.</P>
          <P>
            <E T="03">Comment:</E>One commenter had questions regarding the definition of OPPC. The commenter questioned which evidence-based guidelines would be used and recommended that the regulation be expanded to include exact definitions of the guidelines.</P>
          <P>
            <E T="03">Response:</E>It would be difficult to determine a singular set of guidelines to be identified for the various conditions that States may identify under these provisions. The rule provides States flexibility in determining the conditions identified for nonpayment under their individual State plans. As States submit plans for approval, we will evaluate the conditions proposed by States and determine their appropriateness for the Medicaid program. Additionally, we would remind commenters that the Secretary has the authority to revisit these provisions and may do so as this policy area develops. We reject the commenters recommendation and have made no changes to the final provisions regarding this issue.</P>
          <P>
            <E T="03">Comment:</E>Many commenters recommended that more research be done by Medicare and Medicaid on applying PPC nonpayment policies to outpatient settings before conditions that occur in those settings are incorporated into PPC nonpayment policies or expanded. Some commenters objected to the designation of the 3 NCDs as a baseline for the Medicaid policy.</P>
          <P>
            <E T="03">Response:</E>Medicare is conducting additional research to inform its policy on applying its HAC provisions beyond its IPPS hospitals. In preparing this regulation, CMS was required to consider existing State practices and determine whether, as a matter of policy, it was appropriate to include those established practices in these final regulations. We determined that, in some instances, States had implemented provisions that applied to providers in settings other than inpatient hospital settings, including outpatient hospital settings. We did not believe that it was prudent to require of all States what had been done in a few, but we wanted to provide States the flexibility to do so. Accordingly, we designed the PPC provisions to allow the expansion of State policies to other care settings, and other conditions. We agree that States should do additional research to evaluate the impact of applying nonpayment policies in outpatient settings before adopting such policies. It should also be noted that States with existing policies that do not meet the minimum provisions of this final rule and those without existing policies will need to submit for CMS approval SPAs implementing these policies.</P>
          <P>The three events that we are requiring that States include in their OPPC are those events which already trigger payment reductions in the Medicare program as national coverage determinations (NCDs). In the Medicare program, NCDs are already applied to all providers, not just to specified hospitals. Medicare NCDs are detailed, evidence-based determinations that are supported by substantial data. Therefore, inclusion of these three events merely replicates evidence-based determinations that are already in effect in the Medicare program.</P>
          <P>
            <E T="03">Comment:</E>One commenter stated that the expansion of State PPC policies into non-inpatient settings will be extremely difficult to implement due to the very characteristics that are inherent to the outpatient setting, such as: The types of care and services provided; numerous providers and provider-types involved in care; periodic episodes of care provided by numerous providers over lengthy periods of time; and lack of systems and infrastructure to adequately coordinate care between visits and providers, among others. The wide variety of payment systems create enormous challenges for provider reporting, according to this commenter.</P>
          <P>
            <E T="03">Response:</E>We are encouraging States to work with provider communities and other stakeholders to carefully examine nonpayment policies in non-inpatient settings. Additionally, we are requiring that States submit for approval Medicaid State plan amendments that would implement PPC nonpayment policies. To support these Medicaid State plan amendments, we are clarifying that the State must have made findings that the proposed PPC is reasonably preventable through the application of evidence-based guidelines. The SPA review process will give CMS and providers the opportunity to consider State policy before it is implemented and to provide guidance and input based on our knowledge of the issues.</P>
          <HD SOURCE="HD3">4. POA and Coding Systems</HD>
          <P>
            <E T="03">Comment:</E>Several commenters objected to the burden of creating a POA system and the potential for variation in the different State PPC policies. Commenters are concerned that the POA requirement and its impact on reimbursement may result in extraneous testing, delayed care, and further access issues for Medicaid patients. In emergency situations, it is often impossible to provide optimal patient care and simultaneously determine POA status, it was noted. One commenter also noted that many hospitals were not familiar with the intricacies of POA coding and would require CMS guidance and time to implement it.</P>
          <P>
            <E T="03">Response:</E>The POA system is not required by this final regulation, but obviously providers will need to carefully document the physical status of their patients on admission. That documentation is not simply done for legal purposes, but serves the legitimate medical purpose of allowing for careful evaluation the patient's condition prior to treatment and communicating that information to members of the treatment team. Ultimately, the provider will self-report PPCs to the State. The State may choose to verify this by a POA system or by other methods.</P>
          <P>
            <E T="03">Comment:</E>One commenter disagreed that relying on record review with the “Global Trigger Tool” to detect what is present on admission will be effective in detecting POA. The commenter requested clarification on the method and asserted that it is not CMS's responsibility to determine POA retrospectively. The commenter opined that since CMS is not the patient's care provider, this would be bureaucratic over-reach into the patient-provider relationship.</P>
          <P>
            <E T="03">Response:</E>We agree with the commenter that it is not CMS's responsibility to determine the POA status of a patient. The “Global Trigger Tool” is a tool by which providers would use a series of “triggers” to determine the possible occurrence of an adverse event and indicate further review of a particular case. Neither the proposed rule, nor this final rule include any requirement that a provider implement the use of the “Global Trigger Tool.” We do suggest that our research indicates that this tool may be useful in identifying the occurrence of PPCs, as well as others like nursing reviews or concurrent utilization reviews.</P>
          <P>
            <E T="03">Comment:</E>One State commented that the POA indicator is a very useful resource to identify the specific hospital where an adverse event occurred.</P>
          <P>
            <E T="03">Response:</E>We thank the commenter for this information.</P>
          <P>
            <E T="03">Comment:</E>One commenter was concerned with the use of the POA indicator being applied to pediatric populations because it may be hard to determine whether a child entered an emergency department with an<PRTPAGE P="32825"/>asymptomatic yet incubating infection. This commenter recommended a study be done to determine whether the incubation period in a child is different from an adult because the information would influence the determination of POA in certain cases.</P>
          <P>
            <E T="03">Response:</E>The POA system is not required by this final regulation, but obviously providers will need to carefully document the physical status of their patients on admission. That documentation is not simply done for legal purposes, but serves the legitimate medical purpose of allowing for careful evaluation the patient's condition prior to treatment and communicating that information to members of the treatment team. Ultimately, the provider will self-report PPCs to the State. The State may choose to verify this by a POA system or by other methods.</P>
          <P>In regard to the study of the incubation period of infections in children versus adults, the purpose of this rule is to deny Medicaid payment for PPCs. States will be required to submit SPAs to implement these policies, however, aside from the minimum requirements in the rule States have flexibility in determining how to implement the related provisions, including the conditions identified for nonpayment. That being said, we recognize the inherent differences between the Medicare and Medicaid populations and would note that a major consideration for allowing States such flexibility in the OPPC category is the idea that States will be able to work with their provider communities and industry partners to further consider the unique situation of Medicaid beneficiaries within each State. We realize that for children's hospitals and pediatric populations there are a number of conditions that could be otherwise identified. We believe that States, working with their provider communities, are in a better position to develop additional conditions specific to their Medicaid populations and programs. We continue to believe that innovations should be shared across programs and States. As information becomes available, we will share implementation examples with States. We also encourage States to collaborate in this policy area.</P>
          <P>
            <E T="03">Comment:</E>One commenter recommends that States consistently adopt the ICD-9-CM and ICD-10-CM codes as the only diagnostic standard for identifying conditions for purposes of Medicaid payment. According to this commenter, it would be administratively burdensome for providers, as well as result in lack of data comparability across Medicare and Medicaid programs, to allow Medicaid programs to use alternative coding systems or their own method for identifying each PPC.</P>
          <P>
            <E T="03">Response:</E>We agree that the ICD-9-CM and ICD-10-CM codes present a reasonable alternative to developing and implementing unique diagnostic codes for the purposes of this provision. We encourage States to explore the use of the ICD-9-CM and ICD-10-CM codes for purposes of identifying PPCs under their existing programs.</P>
          <P>
            <E T="03">Comment:</E>One commenter expressed concern over identifying additional costs associated with an adverse event that occurs in a same day surgery center, a skilled nursing facility or a clinic. The commenter reported that it would be very difficult to identify the clinic or facility as the cause of the adverse event because they are not reimbursed through a DRG payment system. The commenter notes that its claims system would not isolate claim lines related to the adverse event to distinguish them from appropriate services.</P>
          <P>
            <E T="03">Response:</E>We appreciate the response. We understand the difficulty that States may face in applying this policy in settings other than inpatient hospital settings, but note that some States have managed to apply these policies quite broadly and successful quality outcomes have resulted. We encourage States to evaluate their populations and work with their provider communities to explore the possibilities of expanding PPC policies to non-inpatient hospital settings to support States efforts to improve the quality of care in their overall health systems.</P>
          <P>
            <E T="03">Comment:</E>One State with hospitals exempt from Medicare IPPS payment under 1814(b)(3) of the Act noted that its existing PPC policy, which started in 2008, has resulted in a 12 percent decrease in measured hospital complication rates with associated cost reductions of $62 million which were subsequently redistributed within hospitals in that State. The State praised CMS for allowing State flexibility in developing PPC policy and outlined planned State initiatives in reducing preventable readmissions. This State also noted that since its policy is considerably expansive, it should be exempted from this final rule.</P>
          <P>
            <E T="03">Response:</E>We do not have legal authority to exempt any State from the statutorily required provisions. We disagree with the suggestion that a States existing policy should exempt a State from the requirements of this final rule. The provisions of the final rule are drafted to allow States flexibility in developing individual PPC policies, while adhering to the minimum requirements set forth. While we appreciate the innovative nature of State programs, we believe that it is necessary for all States to appropriately amend their Medicaid State plans to comply with Federal law. This will also enable other States to learn and be better informed.</P>
          <P>We also believe that this comment illustrates the value of the Federal-State partnership in Medicaid. Many of the ideas used in this regulation were originally developed by State Medicaid programs interested in improving the quality of care received by their Medicaid beneficiaries. States, like other stakeholders in the Medicaid system, share a common interest in the development of safe, efficient Medicaid systems which serve their beneficiaries. A common goal for CMS, States, providers and patients is the pursuit of better outcomes for individuals and populations, while reducing unsustainable costs through improved quality of care. The pursuit of this common goal strengthens not only Medicaid, but the entire American health care system.</P>
          <P>
            <E T="03">Comment:</E>Some commenters were strongly supportive of the approach taken by the proposed regulation. The commenters endorsed the use of the Medicare HAC as Medicaid HCAC and the provision of flexibility to States through the SPA process. In particular, one group favored the preservation of State ability to define PPC which occurred outside of hospitals and the three federally required OPPC. This commenter stressed the value of required State reporting systems and suggested public posting of such data after appropriate risk-adjustment and data validation. The comment also noted the importance of CMS monitoring to assure that the PPC policy had no adverse effects on beneficiary access to care.</P>
          <P>
            <E T="03">Response:</E>We appreciate the commenters' support. We will monitor the implementation of the final rule to assure that beneficiary access to care is not impaired.</P>
          <HD SOURCE="HD3">5. General Comments</HD>
          <P>
            <E T="03">Comment:</E>One commenter believes that the proposed rule is inconsistent because it states that hospitals will need additional infection control staff to prevent or reduce PPCs and that hospitals already have programs in place. The commenter also asks for clarification on whether the implementation cost estimates are academic or provided by hospitals.</P>
          <P>
            <E T="03">Response:</E>The commenter is taking these two points out of context. In the<PRTPAGE P="32826"/>preamble to the proposed rule in discussing options considered for reporting requirements we say, “We considered requiring reporting to Hospital Compare and the National Health Safety Network, but decided against these formats because: We do not believe they currently have the capacity to allow State specific reporting of varied measures; their existing collections may not be consistent with what most States are currently requiring providers report; and the reporting formats may impose undue significant burden for providers—particularly those that do not have full-time quality staffs or resources.” Later in the proposed rule where we discuss the regulatory impact analysis we state, “The Joint Commission requires hospitals to have established programs for Quality Improvement, Risk Management, Safety, and Infection Control. As a result, a majority of hospitals already have in place programs to avert Medicare HACs and thus would not incur new costs to implement parallel programs to avert Medicaid HACs.” There are hospitals that have existing programs. There are also hospitals that will need to use additional resources to meet State requirements. This will be determined by each individual hospital depending upon its existing resources. The estimates are based on our experience with the implementation of like provisions through the SPA process, as well as Medicare's experience implementing its HAC policy.</P>
          <P>
            <E T="03">Comment:</E>Commenters were concerned that States would be too expansive in defining outpatient PPCs and noted that, in the outpatient area, there is limited provider control and patient compliance issues are essential.</P>
          <P>Another commenter expressed concern that the provisions would allow States to identify conditions not based on accepted medical standards. It noted that, in its State, the automated Medicaid claims system used by Medicaid health plans had limited ability to report out or adjust for PPCs. The commenter was critical of the short timeline for compliance and expressed concern that, in the dual eligible category, there was a possibility of double payment reduction.</P>
          <P>
            <E T="03">Response:</E>We note that an OPPC must be supported by a finding by the State that it “could have reasonably been prevented through the application of evidence-based guidelines.” To address this comment, we have strengthened this language to require that the finding be based on a review of medical literature by qualified professionals. As a result, States PPCs will not be able to identify a PPC without a strong basis to do so, and we do not anticipate great variation between States over time.</P>
          <P>We are requiring that the providers self-report PPCs, at which time the health plan or State can, upon receipt of the self-report, make an appropriate payment correction. We believe that, once providers have put in place systems to track and report PPCs, they will be able to use this information to reasonably reduce the incidence of these defined events in their facilities. For dual eligibles, the intent of this rule is that no payment would be available under either Medicare's IPPS or Medicaid for an identified HAC. We do not view this as a “double payment reduction” but as a consistent nonpayment policy. State Medicaid agencies have repeatedly expressed to CMS their concern that, with dual eligibles, the impact of a Medicare HAC denial was often that the provider would simply bill Medicaid as a secondary payer. This would result in no denial of payment even when a Medicare HAC occurred. Indeed, that complaint from State Medicaid agencies is one of the reasons that, in this regulation, we are attempting to coordinate Medicare and Medicaid policies.</P>
          <P>
            <E T="03">Comment:</E>Several commenters suggested that we develop a set of standard definitions that account for provider setting and other evidence-based factors that can be applied across health care settings and across State lines. Some also suggested that we remove the option providing States the ability to include any HCACs or OPPCs beyond those required by Medicare to encourage State-to-State uniformity.</P>
          <P>
            <E T="03">Response:</E>Medicaid is a State-administered program. By setting Medicare's hospital IPPS HAC policy as the base policy, we are encouraging uniformity across the two programs while simultaneously allowing States to retain the flexibility that is statutorily-afforded to them under title XIX of the Act.</P>
          <P>
            <E T="03">Comment:</E>One commenter questioned what would prevent hospitals from spreading the cost of nonpayment for PPCs out among all health care consumers. The commenter suggested that CMS institute an incentive system by implementing a pre-paid provider incentive pool rather than a nonpayment system.</P>
          <P>
            <E T="03">Response:</E>The purpose of this regulation is to establish rules that would prevent Medicaid from paying for HCACs resulting from provider error and to encourage quality-based reimbursement. Hospitals will continue to be paid for the services provided. If a patient enters the facility for a surgical procedure and in the process of that procedure a HCAC occurs, the hospital will receive payment for the initial surgical procedure but will not receive payment for services provided in addressing the HCAC. That being said, this final rule sets out broad parameters for allowing States to design PPC policies that complement their current systems. If a State is able to develop a system that complies with the requirements of this final rule through an incentive based program, we welcome the opportunity to review it as part of a SPA and share it with other States as appropriate.</P>
          <P>
            <E T="03">Comment:</E>Some commenters asked CMS to provide in the final rules specific guidance to States regarding the inclusion of additional preventable conditions; for example, issue specific, evidence-based parameters for defining “preventable” with consideration for issues like patient noncompliance. Other commenters provided specific conditions that they did not believe States should identify for nonpayment in their PPC policies. The commenters had various reasons for objecting to States' inclusion of these conditions based on patient population, facility type, and administrative burden.</P>
          <P>
            <E T="03">Response:</E>The final rule does not require that States include other provider preventable conditions, but provides States with the option to do so. By allowing States to develop these programs through State plan amendments with the participation of the provider community, we believe that concerns such as this will be addressed at the State level.</P>
          <P>
            <E T="03">Comment:</E>One commenter highlights the fact the PPCs program's impact on States includes the administrative and financial burden of building and maintaining data collection systems, not to mention the reality that State Medicaid programs are run by public administrators who may not have training or experience in clinical issues, comparative effectiveness research, and other factors that are critical when making payment restriction decisions.</P>
          <P>
            <E T="03">Response:</E>We agree that States may need to employ additional resources to implement a PPC policy, just as with any other payment policy implemented by States. The minimum requirements under this final rule are designed to minimize the administrative burden on all stakeholders. The PPC policy is designed to use existing data systems to identify conditions as they occur. We encourage States and providers to work together to craft comprehensive PPC nonpayment and reporting policies that are reasonable and effective.<PRTPAGE P="32827"/>
          </P>
          <P>
            <E T="03">Comment:</E>One commenter noted that payment reductions for those hospitals that have a high burden of Medicaid and Medicare patients will challenge their ability to stay open at current capacity if they suffer significant payment reductions due to the new rule. Critical access hospitals may be the most vulnerable due to the lack of infrastructure to analyze their own data and develop corrective actions prior to the actual payment reductions, according to the commenter.</P>
          <P>
            <E T="03">Response:</E>Hospitals will continue to be paid for the provision of high quality care under the final rule. The Affordable Care Act requires that HACs identified under Medicare IPPS rules are applicable to all entities that operate as Medicaid inpatient hospitals. We do not have the authority to exempt any Medicaid inpatient hospital providers from these requirements.</P>
          <P>
            <E T="03">Comment:</E>One commenter noted that under Medicare, the cost savings seems relatively low as it pertains to all of the HACs, which is the baseline for this policy under Medicaid. According to this commenter, there is very little data to suggest that the savings under Medicaid would be greater even if the OPPCs are included. The commenter recommend that CMS take a slower approach to broadening the HCAC policy by expanding from the Medicare HACs over a longer period of time to evaluate the savings from nonpayment for HCACs under the Medicaid program.</P>
          <P>
            <E T="03">Response:</E>The purpose of this regulation is to drive quality care, it is not a cost savings exercise. We recognize there may be some cost savings and that it may take some time to realize the full extent of the cost savings, but this measure is important for the long-term benefit of the Medicaid program, Medicaid beneficiaries, and the health care industry as a whole. We intend for these provisions to be a catalyst for change where the infrastructure for quality measurement, as well as the methods for improvement that should be built into our system, are not currently in place.</P>
          <P>
            <E T="03">Comment:</E>One commenter wrote to share its success in quality improvement within a particular State. The commenter reported various collaborations that it has undertaken with its State and other stakeholder organizations resulting in delivery system innovations have proven valuable and efficient.</P>
          <P>
            <E T="03">Response:</E>We appreciate this comment and commend the commenter for taking the necessary steps to improve care to its beneficiaries. We encourage other States and organizations to innovate in the same way.</P>
          <P>
            <E T="03">Comment:</E>One commenter recommended that national clinical consensus should be a component of the criterion as to whether a condition is “reasonably preventable.”</P>
          <P>
            <E T="03">Response:</E>We agree that a finding as to whether a condition is “reasonably preventable.” must be based on a solid basis in national medical literature, as determined by qualified professionals. Therefore, we are retaining and strengthening the portion of the OPPC definition from the proposed rule that requires that conditions identified by States must be supported by a finding that the conditions, “could have reasonably been prevented throughevidence-based guidelines.” We are adding that this State finding must be based upon a review of medical literature by qualified professionals. We believe that this stronger language will ensure a level of integrity and consistency in these determinations.</P>
          <P>
            <E T="03">Comment:</E>One commenter believed that Medicare has determined and will continue to determine, with the help of evidence-based guidelines, what is reasonably preventable and what are “never events,” and that this should be the standard across all regions of the country because there would not be any benefit to the population of beneficiaries for one state to have different quality health standards including for payment consideration.</P>
          <P>
            <E T="03">Response:</E>The work that Medicare has done in the process of developing its IPPS HAC policy is valuable and consistent. Adopting this work on a national level will benefit States and beneficiaries. This is part of the reason the final regulation incorporates conditions identified as Medicare's HACs, with the exception of DVT/PE as related to total knee replacement and total hip replacement for pediatric and obstetric populations, and 3 NCDs as the foundation of the Medicaid policy to be applied in States.</P>
          <P>
            <E T="03">Comment:</E>One commenter believed, in regard to flexibility as to the grouper that each State selects to use to process HCAC, that to achieve consistency there needs to be limits placed on the choice. Also, States need to be using the current HIPAA administrative code set versions that Medicare uses. This commenter also supported the standardization of public domain groupers to help reduce the cost to healthcare providers and States.</P>
          <P>
            <E T="03">Response:</E>States have great flexibility in designing their own payment systems and working with their provider communities in determining how best to implement these provisions. We do not intend to restrict that flexibility with this final rule. We note that not all States reimburse providers using grouper methodologies. In regard to the adoption of the standardization of public domain groupers, we appreciate this comment, but it is outside the scope of this rule.</P>
          <P>
            <E T="03">Comment:</E>Many commenters recommended that we revise Medicare's HAC list to include or eliminate various conditions.</P>
          <P>
            <E T="03">Response:</E>We thank the commenters for their input. However, revisions to Medicare's IPPS HAC list are outside the scope of this rule.</P>
          <P>
            <E T="03">Comment:</E>Some commenters wrote requesting clarification of or on the application of Medicare's HAC list.</P>
          <P>
            <E T="03">Response:</E>The commenters' requests are outside the scope of this rule. We refer the commenter to the Medicare HAC page located at<E T="03">http://www.cms.gov/HospitalAcqCond/02_Statute_Regulations_Program_Instructions.asp#TopOfPage.</E>
          </P>
          <HD SOURCE="HD3">6. State Plan Amendments</HD>
          <P>
            <E T="03">Comment:</E>One State noted that the preamble (see 76 FR 9289) proposes that States would be required to amend their Medicaid State plans to match any changes to Medicare's final IPPS rule that Medicare publishes 60 days prior to the beginning of the next Federal fiscal year. The State commented that 60 days does not allow enough time to identify ways to capture the data and program and test changes to the payment system. The State suggested that CMS clarify that a State could comply by the submission of a State plan amendment by the end of the Federal quarter in which the change takes effect, that is, by the end of the first quarter of the next Federal fiscal year.</P>
          <P>
            <E T="03">Response:</E>The Medicaid SPA process requires that States submit amendments to their Medicaid plans no later than the last day of the quarter in which the amendment would take effect. We have developed a State plan preprint that outlines the minimum provisions of this final rule and allows States the flexibility to identify OPPCs for nonpayment in their Medicaid State plans. States will define the related payment methodologies within the appropriate sections of their Medicaid State plans.</P>
          <HD SOURCE="HD3">7. Reporting Requirements</HD>
          <P>
            <E T="03">Comment:</E>One commenter recommended that reporting requirements be included in States' provider policies and included in provider contracts.</P>
          <P>
            <E T="03">Response:</E>As discussed in the proposed rule, a reporting component is<PRTPAGE P="32828"/>essential to building an effective PPCs policy for a number of reasons, including State and CMS ability to capture data related to these occurrences. We believe that States will need to work with their provider communities to implement an appropriate reporting system.</P>
          <P>
            <E T="03">Comment:</E>One commenter supports the requirement that existing claims systems be used as a platform for provider self-reporting because it is essential that their nonpayment policies are based on data provided through their claims systems.</P>
          <P>
            <E T="03">Response:</E>We thank the commenter for support on this issue.</P>
          <P>
            <E T="03">Comment:</E>One commenter remarked that provider self-reporting procedures should require providers to report conditions identified for nonpayment when they occur, regardless of the provider's intention to bill. Hospitals and providers have a clear incentive not to report quality errors beyond nonpayment provisions, according to the commenter. CMS must take a strong stance against underreporting and apply strict penalties. Another commenter requested that CMS clarify that States would be required to submit provider self-reporting data to CMS.</P>
          <P>
            <E T="03">Response:</E>In Medicaid, States are given a large degree of flexibility under title XIX of the Act. As such, providers submit Medicaid claims to States and not CMS. While we are requiring that States implement self-reporting requirements, States have the ability under the statute to determine how they will implement these requirements with input from the provider communities. Once data is collected at the State level, States will submit that data to CMS as part of their standard procedure for collecting and sharing Medicaid provider claims data.</P>
          <P>
            <E T="03">Comment:</E>Several commenters supported provisions in the proposed rule that would require States to implement provider self-reporting requirements through the claims submission processes.</P>
          <P>
            <E T="03">Response:</E>We agree and have retained these provisions in the final rule.</P>
          <P>
            <E T="03">Comment:</E>A few commenters believe that providers will be over burdened with the reporting requirements under this new regulation. Additionally, they disagreed with how long it would take States to develop and implement reporting requirements.</P>
          <P>
            <E T="03">Response:</E>The provisions of this final rule require reporting through State claims systems because they are existing resources that are routinely and regularly modified to accept State payment adjustments for other provisions. Most providers subject to the minimum requirements of the final provisions will be familiar with when and how to report these conditions. In States with existing policies, there are already these types of reporting requirements for payment purposes. And, States electing to go beyond the minimum requirements of these provisions will need to work with their provider communities to ensure that all aspects of the provisions can be sufficiently implemented. Provider reporting is necessary to ensure that the payment preclusion is effective in eliminating PPCs, or determine whether additional measures may be required, or whether the measures applied are necessary.</P>
          <P>
            <E T="03">Comment:</E>One commenter requested clarification on the purpose of provider reporting and how CMS expects States to use reported information. Another commenter noted that there is no clear provision on how States are to report this data to CMS. One State asks whether the SPA will have to specify how the reporting will be done, or if States will need to assure that they will comply with the requirement.</P>
          <P>
            <E T="03">Response:</E>We are requiring that States impose provider self-reporting through claims systems because that information will be used to determine when a PPC occurred and trigger State payment action. The data will also be fed by States to CMS. CMS and States will use this data to inform policy making.</P>
          <P>
            <E T="03">Comment:</E>One commenter noted that the proposed rule requires States to establish a provider reporting requirement for PPCs. The commenter asked what the parameters will be for those guidelines and how much latitude CMS will give to the States.</P>
          <P>
            <E T="03">Response:</E>As a requirement of the final rule, States will implement the provider self-reporting through payment claims systems regardless of the provider's intention to bill. We are working to ensure that States consistently report at least the minimum requirements of the rule through the Medicaid Management Information Systems (MMIS). We anticipate that States and providers, especially those groups of providers that have not been subject to Medicare's HAC policy, will need to work cooperatively to develop and implement reporting systems that would complement existing payment structures. As discussed in the proposed rule, a reporting component is essential to building an effective PPCs policy for a number of reasons, including State and CMS ability to capture data related to these occurrences.</P>
          <HD SOURCE="HD3">8. Medicare and Medicaid Dual Eligibles</HD>
          <P>
            <E T="03">Comment:</E>One commenter supports nonpayment for all PPCs as they pertain to the dual eligible population. This commenter urges CMS to codify provisions that prohibit Medicaid claim payment for claims that have been denied by Medicare based on the presence of a HAC.</P>
          <P>
            <E T="03">Response:</E>We agree. This is a significant area of concern, and we have revised the final regulation to reflect that no FFP is available for a Medicare denied claim based on the presence of a HAC, “A State plan must provide that no medical assistance will be paid for `provider-preventable conditions' as defined in this section; and as applicable for individuals dually eligible for both the Medicare and Medicaid programs.”</P>
          <P>
            <E T="03">Comment:</E>Some commenters requested clarification on how these provisions would apply to Medicare cross over claims. Commenters wanted clarification on how to determine that Medicare has rejected a HAC claim for an individual dually eligible for Medicare and Medicaid.</P>
          <P>
            <E T="03">Response:</E>We agree that the proposed provisions lacked clarity in the application to individuals dually eligible for Medicare and Medicaid. We have revised the final rule to provide clarification. States may determine that Medicare has reduced payment based on the provisions of its HAC policy by working with their Medicare Fiscal Intermediary to identify the appropriate codes related to treatment for dually eligible individuals. Reference materials regarding POA coding for Medicare HACs may be found at<E T="03">https://www.cms.gov/HospitalAcqCond/05_Coding.asp#TopOfPage</E>
          </P>
          <P>To support State efforts, we will work with the Federal Coordinated Health Care Office to provide guidance on this issue.</P>
          <HD SOURCE="HD3">9. Managed Care</HD>
          <P>
            <E T="03">Comment:</E>One commenter wrote in support of the provision requiring States to modify their managed care contracts to reflect the PPCs payment adjustment.</P>
          <P>
            <E T="03">Response:</E>We agree and are retaining requirements that States include PPC payment restrictions in managed care contracts. All providers should be held to these quality standards and the final rule retains these requirements.</P>
          <P>
            <E T="03">Comment:</E>One commenter requested clarification of the expectation for MCOs to refund money derived from the nonpayment of PPCs back to States.</P>
          <P>
            <E T="03">Response:</E>We anticipate that savings gained from the application of State PPC policies to their managed care providers<PRTPAGE P="32829"/>will, ultimately, be factored into the individual contract rates established with those providers.</P>
          <P>
            <E T="03">Comment:</E>One commenter requested clarification that the amendments to § 434.6 do not apply to MCOs, and further, that the MCO contracts with providers will not have to require providers to report PPCs associated with claims to the MCOs.</P>
          <P>
            <E T="03">Response:</E>On its own, the provisions of § 434.6 do not apply to MCOs; however, by cross-reference, we are applying the specific provision in § 434.6(a)(12) regarding PPCs to MCO contracts. We do intend that MCO contracts with providers, identical to Medicaid State agency's contracts with providers, require those providers to report PPCs associated with claims to the MCO. Further, so that the Medicaid State agency will be able to quantify and report, if necessary, information on all PPCs in the Medicaid program, we expect that MCOs will track PPC data and make it available to the State upon request. Accordingly, we are modifying the proposed § 438.6 to clarify both intentions.</P>
          <P>
            <E T="03">Comment:</E>A few commenters requested that CMS provide guidance for States on how to apply the nonpayment requirement for HCACs to capitation payments, specifically those under § 438.6. Additionally, the commenters requested information on how these policies would apply to the development of actuarially sound rates.</P>
          <P>
            <E T="03">Response:</E>We believe that the implementation of State PPCs policies will be consistent with what we anticipate in the fee-for-service setting and have only minimal impact on provider payment and therefore the development of actuarially sound rates. However, as the MCOs spend less money on services, that decrease will be reported to the State which will in future rate-setting reflect the reduced expenditures in the rate setting. States will need to work with their MCOs to develop appropriate policies within their contracts.</P>
          <P>
            <E T="03">Comment:</E>One commenter recommended that CMS reinforce the importance of State compliance with the requirement that Medicaid managed care rate setting must be actuarially sound.</P>
          <P>
            <E T="03">Response:</E>The requirements of this final rule do not in any way preempt regulatory provisions otherwise in effect. We urge States to work with all of their provider communities to determine the best ways in which to implement related nonpayment policies.</P>
          <HD SOURCE="HD3">10. Comment Period</HD>
          <P>
            <E T="03">Comment:</E>A few commenters objected to the 30-day comment period. One commenter proposed that CMS issue a final rule with comment period to accept additional public comment and to provide additional time for States to articulate how they might comply with the regulations.</P>
          <P>
            <E T="03">Response:</E>This rule does not present a high level of complexity and we believe that the 30-day comment period provided commenters sufficient time to fully evaluate the proposed rule and submit comments to CMS. The 30-day comment period is consistent with the requirements of the Administrative Procedure Act codified at 5 U.S.C. 553, and a longer period is not warranted in light of the significant beneficiary protection that this rule would implement. For the same reasons, we do not agree that issuing a final rule with comment period is necessary.</P>
          <HD SOURCE="HD2">B. Access to Care</HD>
          <P>Section 2702(a) of the Affordable Care Act requires that the Secretary ensure that adjustments to payment rates under this section do not result in a loss of access to care for beneficiaries. To this end, we proposed that any reduction in payment would be limited to the amounts directly identifiable as related to the PPC and the resulting treatment.</P>
          <P>We received the following comments in response to our proposals concerning access to care.</P>
          <P>
            <E T="03">Comment:</E>One commenter stated that hospitals should not be penalized multiple times for the same occurrence.</P>
          <P>
            <E T="03">Response:</E>We agree and urge provider communities to engage States to ensure that methodologies implemented do not unduly impact providers.</P>
          <P>
            <E T="03">Comment:</E>Several commenters requested that we include a provider appeals process in these provisions. The commenters noted that the nature of identified conditions and the variation in State payment policies warranted the inclusion.</P>
          <P>
            <E T="03">Response:</E>Existing State appeal processes may be available for a provider to contest whether a State has improperly identified the occurrence of a condition identified as a PPC. We encourage States to develop appeals processes that will allow providers to object to any payment reduction when the provider can show that an identified PPC occurred despite all appropriate precaution.</P>
          <P>
            <E T="03">Comment:</E>Some commenters opined that allowing States any flexibility in defining PPC through the OPPC category would be an undue burden on providers who operate on a multistate basis.</P>
          <P>
            <E T="03">Response:</E>The underlying authority for this rule is found in provisions of title XIX of the Act that predated section 2702 of the Affordable Care Act. The proposed rule was supported by our existing authority under sections 1102, 1902(a)(19), and 1902(a)(30) of the Act. Providers that operate on a multistate basis must comply with the laws and rules of each State in which they operate. We see no compelling reason to limit State flexibility to identify PPC nonpayment rules to ensure high quality services for beneficiaries.</P>
          <P>
            <E T="03">Comment:</E>One commenter opposed the idea of States being allowed to define potential PPC and opined that this task was better left to national quality organizations such as NQF or IOM. While expressing support for the general concept of evidence-based quality standards, the commenter believed that it was important that these standards be national in scope and that the use of State Medicaid payment systems was not the appropriate vehicle for improvement of health care quality.</P>
          <P>
            <E T="03">Response:</E>The Medicaid program, by its very nature, is a partnership between the Federal and State governments, and is administered by States. While we are requiring that States rely on a review of medical literature by qualified professionals to identify evidence-based PPCs, we believe it is essential to allow States flexibility to develop payment strategies that provide strong incentives for high quality services.</P>
          <P>
            <E T="03">Comment:</E>Several commenters recommended that we limit State ability to create PPCs to only those which strictly met the Medicare criteria in section 1886 (d)(4)(D)(iv) of the Act.</P>
          <P>
            <E T="03">Response:</E>Section 2702 of the Affordable Care Act requires that the Secretary by rulemaking, establish a nonpayment policy for HCACs, the underlying authority for this rule is found in provisions of title XIX of the Act. The proposed rule was supported by our existing authority under sections 1102, 1902(a)(19), and 1902(a)(30) of the Act and States, using this authority, have already undertaken payment policies to drive quality outcomes. We see no compelling reason to limit State flexibility to identify PPC nonpayment rules to ensure high quality services for beneficiaries.</P>
          <P>
            <E T="03">Comment:</E>One commenter was supportive of the proposed regulation and of the addition of non-hospital providers through the OPPC category. The commenter suggested careful CMS scrutiny of proposed State PPC SPAs to assure no adverse impact on beneficiary access to care, the addition of a risk-adjustment mechanism to the regulation, careful monitoring to assure<PRTPAGE P="32830"/>that no access problems develop, and some mechanism to publicly report provider outcomes. The Maryland Medicaid model for PPC payment and reporting was offered as an exemplary model for national use.</P>
          <P>
            <E T="03">Response:</E>We reviewed the Maryland system in developing this regulation and, found it to be a useful State model that combined both financial incentives with overall quality improvement efforts. CMS will review State preprints, reimbursement State plan amendments, and supplementary information to determine final action on State PPC policies.</P>
          <P>
            <E T="03">Comment:</E>Some commenters expressed concern that the proposed regulation allowed too much discretion to individual States to use the SPA process to affect payment in areas where no national consensus about appropriate care existed.</P>
          <P>
            <E T="03">Response:</E>We are strongly committed to permitting State flexibility to innovate in this area. State innovation has been a significant driver of Federal policy, and States have direct experience with utilization and claims review for Medicaid services. While we anticipate that States will review data to identify evidence-based PPCs, we believe it is essential to allow States flexibility to develop payment strategies that provide strong incentives for high quality services.</P>

          <P>The SPA review process will give CMS and providers the opportunity to consider State policy before it is implemented and to provide guidance and input based on our knowledge of the issues<E T="03">.</E>
          </P>
          <P>
            <E T="03">Comment:</E>Several commenters expressed concern that the language of the proposed regulation allowed States excessive authority to use the PPC process to further reduce Medicaid compensation during a period when States are already under financial pressure to reduce Medicaid costs. One commenter suggested numerous additional limitations of State use of the PPC process be added to the final regulation.</P>
          <P>
            <E T="03">Response:</E>This final rule provides for nonpayment to the extent that an identified PPC would otherwise result in an increase in payment for additional services, and permits States to identify PPCs in addition to the core PPCs that are based on Medicare. This is consistent with the considerable flexibility that States have in setting payment rates and methodologies. States will need to file SPAs with CMS outlining the State's proposed nonpayment methodology, and their approach to inclusion of Federal minimum standards, as well as any additional variations proposed by the State. The SPA process will allow the State's providers to file public comments on any proposed State changes.</P>
          <P>
            <E T="03">Comment:</E>Several commenters expressed concern over how the nonpayment policy would be implemented in States that do not use MS-DRG reimbursement systems. A few commenters requested that States that have elected to use per-diem, global payment, bundled payment or other non-MS-DRG systems to reimburse hospitals be allowed to continue to do so, and not be forced to move to MS-DRG.</P>
          <P>Commenters were concerned that these States will need to identify methods appropriate to their reimbursement mechanisms to make payment reductions for PPCs and that resource-intensive post payment audits and payment adjustments are likely to be necessary. These commenters noted that they are encouraged by our attempt to provide flexibility to States, but requested that we issue guidance that includes best practice recommendations for developing efficient payment adjustments where reimbursement is not based on an MS-DRG system. Another commenter requested that we provide options for how States may identify or estimate the cost of services on a systematic basis without a case by case review. One commenter requested that we develop a crosswalk of HCAC conditions to non-DRG payment methodologies to assure consistency in reporting from States back to CMS. The commenter remarks that encouraging States and MCOs to create their own crosswalks will be counter-productive.</P>
          <P>
            <E T="03">Response:</E>CMS recognizes that many States do not use MS-DRG to reimburse hospital providers. As stated in the NPRM, we have no intention of requiring States to alter their current compensation systems to comply with this final regulation beyond the necessary adjustments needed to implement the PPCs non-payment provisions. This intention continues through the final rule.</P>
          <P>States have flexibility to design their own payment systems within the guidelines of Federal regulations. The final rule allows States the flexibility to implement nonpayment policies through various mechanisms, but requires that States submit Medicaid SPAs setting forth their mechanism to comply with the required nonpayment for PPCs, with public notice for CMS approval. States will need to work with their provider communities, industry partners, and CMS to determine the most effective manner in which to implement these nonpayment provisions. As we noted in the preamble to the proposed rule, we intend to continue to gather and share information related to States' implementation of PPCs nonpayment policies. However, we do not intend to endorse any particular best practices.</P>
          <P>We do not wish to limit State flexibility by dictating methods in which PPCs should be translated or “cross walked” to individual State payment systems. However, we do agree that there is a need for as much consistency as possible in reporting from States to CMS. As a requirement of the final rule, States will implement the provider self-reporting through payment claims systems regardless of the provider's intention to bill. We are working to ensure that States consistently report at least the minimum requirements of the rule through the Medicaid Management Information Systems (MMIS). We anticipate that States and providers, especially those groups of providers that have not been subject to Medicare's HAC policy, will need additional time to develop and implement reporting systems that would complement existing payment structures. As discussed in the proposed rule, a reporting component is essential to building an effective PPC policy for a number of reasons, including State and CMS ability to capture data related to these occurrences.</P>
          <P>
            <E T="03">Comment:</E>A few commenters believed that it is unjust to penalize providers for complications that occur despite best evidence-based efforts to eliminate or avoid them. Commenters noted that some conditions have more to do with patient risk factors or patient compliance than with quality of care. Another commenter stated that not covering these conditions would encourage denial of care to high risk patient or a mass exodus of providers. Several commenters suggested that appeals processes be included in State Medicaid PPCs provisions that would allow providers to challenge payment denials.</P>
          <P>
            <E T="03">Response:</E>We agree that not all of the identified events will be avoidable in 100 percent of the cases even with appropriate precautions. But current Medicaid payment systems are designed to provide incentives to providers to efficiently provide high quality care and result in an aggregate payment that may be more or less than actual costs in a particular case. For example, payment is often based on a fee schedule or diagnosis related group methodology that considers average or target costs of the particular service or services and may differ from actual costs in a<PRTPAGE P="32831"/>particular case. Even “reasonable cost” rates do not necessarily include all costs a provider may incur. It is important to remember that the identified conditions have been determined through evidence-based medicine to be provider preventable. For the issue of appeal rights, existing State appeal processes may be available for a provider to contest whether a State has improperly identified the occurrence of a condition identified as a PPC. We encourage States to develop appeals processes that will allow providers to object to any payment reduction when the provider can show that an identified PPC occurred despite all appropriate precaution.</P>
          <P>
            <E T="03">Comment:</E>One commenter suggested, as an example, that we consider permitting Medicaid coordinated care plans to adopt inpatient concurrent review as a practice for addressing PPCs. The commenter noted that, “most Medicaid coordinated care plans utilize inpatient concurrent review as a unique reimbursement practice for addressing PPCs. Most Medicaid coordinated care plans utilize inpatient concurrent review to identify hospital days that are not medically necessary or represent delays in care. These days are generally not eligible for reimbursement in a non-DRG/per-diem environment. Expanding the concurrent review process to include identification of hospital days required solely for the treatment of PPCs would be one way to address this issue.”</P>
          <P>
            <E T="03">Response:</E>This is one example of how States may be able to identify amounts related to the treatment of PPCs. The final rule indicates that States may reduce payments to providers when the PPC would otherwise result in an increase in payment. The rule also requires that the State be able to reasonably isolate for nonpayment the portion of payment directly related to treatment for, and related to, the PPC. The rule does not limit State flexibility in accomplishing these requirements.</P>
          <P>
            <E T="03">Comment:</E>One commenter asked that we clarify that it recognizes that different reimbursement methodologies may result in no reduction or different reductions than the reductions under MS-DRGs. Another commenter asked that we confirm that, “if on the same inpatient hospital day, both services associated with a PPC and services not associated with a PPC are rendered and if payment is made on a per diem basis such that the presence of the PPC services would not result in an increased per diem payment even without this proposed regulation, then no adjustment to the payment for that day is necessary.”</P>
          <P>
            <E T="03">Response:</E>We agree that given the variations in Medicaid payment methodologies and systems across States, there may be differences in amounts identified for nonpayment based on the payment system employed by the individual State. And there is no requirement that State Medicaid payment adjustments to providers correlate specifically to Medicare's payment adjustments for those same conditions. Payment methodologies are extremely complex, and we do not believe it is productive to address broad hypothetical scenarios regarding implementation of nonpayment policies. We intend to work with each State to develop implementation strategies that make sense with its particular payment methodologies.</P>
          <P>
            <E T="03">Comment:</E>Some commenters recommended that risk-adjustment be incorporated into PPCs policies.</P>
          <P>
            <E T="03">Response:</E>These comments appear to refer to payment methodologies that provide for case-mix adjustments to give higher payments to providers that treat sicker populations, to reflect the higher cost of treating such populations. Such methodologies are not related to the policies relating to PPCs that are reflected in this rule, and to combine the two would significantly weaken the incentives for providers to institute preventive measures to eliminate PPCs. We note that we strongly support the incorporation of risk-adjustment in State Medicaid programs, which States can elect under current law. We are urging provider communities to continue to work with States to develop successful risk-adjustment approaches on the State level.</P>
          <P>
            <E T="03">Comment:</E>One commenter suggested that hospitals which serve Medicare and Medicaid beneficiaries will decrease in quality as a result of the proposed policy because the fixed costs associated with providing medical services will become variable, and instead of absorbing the loss, investors will simply reduce capital investments. The commenter offers that one solution to this possible undesired consequence is to have the Medicaid and Medicare programs absorb such costs, albeit not through direct payments. Instead, the commenter suggested CMS could pay a flat rate at the beginning of the year covering all PPCs and require them to be fully serviced without charge. This way, they will still have the incentive to reduce HCACs but will not have to bear the costs.</P>
          <P>
            <E T="03">Response:</E>The policy set forth in this rule is designed to improve quality of services by providing a strong incentive for providers to take steps eliminate the incidence of preventable conditions. A provider that does so will suffer no economic loss. In contrast, the flat rate payment approach proposed by the commenter would lock in a tolerance level for such conditions, instead of eliminating them, and would send a mixed message to providers about whether providers must take steps to eliminate preventable conditions.</P>
          <HD SOURCE="HD2">C. Effective Date of the Final Provisions</HD>
          <P>Consistent with the provisions of section 2702(a) of the Affordable Care Act, we proposed to make these requirements effective July 1, 2011. In the proposed rule, we requested that States submit conforming SPAs to implement these provisions prior to that date. To be in compliance with the July 1, 2011 effective date, under § 430.20, we proposed that the last date a SPA may be submitted is September 30, 2011, which is the last day of the quarter in which the amendment would be effective.</P>
          <P>We received the following comments in response to our proposals concerning the effective date.</P>
          <P>
            <E T="03">Comment:</E>Several commenters expressed concern that the July 1, 2011 effective date of the rule does not leave sufficient time for discussion of policy, implementation of required hospital changes, and development of the appropriate systems for reporting. Additionally, commenters suggested that States be permitted up to 60 days to incorporate Medicare HACs as Medicare updates its list.</P>
          <P>
            <E T="03">Response:</E>We are statutorily-required to implement these regulations effective July 1, 2011. We do believe, however, that States may need additional time to work with providers to implement sound policies and reporting mechanisms. We intend to delay compliance action on these provisions until July 1, 2012.</P>
          <P>We disagree that this final rule should provide States up to 60 days to incorporate additional Medicare HACs as Medicare's list changes. The publication of Medicare's final IPPS rule is consistent and published in ample time to allow States to incorporate HAC changes. The Medicaid SPA process allows States sufficient time to propose and incorporate any changes that Medicare may make to its HAC list considering the timeframe in which Medicare publishes its final rule.</P>
          <P>
            <E T="03">Comment:</E>One commenter recommended that CMS not penalize States that are not prepared to implement the proposed Medicaid nonpayment policy or any future updates in a timely manner due to a vender not modifying necessary software in a timely manner.<PRTPAGE P="32832"/>
          </P>
          <P>
            <E T="03">Response:</E>States have great flexibility in administering their programs. We urge States to work with their provider communities and vendors to ensure that they meet the provisions of these rules in a timely fashion.</P>
          <HD SOURCE="HD2">D. Specific Revisions to Regulations Text</HD>
          <P>The provisions of the proposed rule would deny FFP for Medicaid expenditures made for PPCs, including HCACs and OPPCs identified in the State plan; and would ensure that related payment adjustments do not limit beneficiary access to care. These provisions, as proposed, would apply to payments as specified under States' approved Medicaid State plans, effective no later than July 1, 2011. We proposed to modify the regulations at 42 CFR parts 434, 438, and 447 following general provider payment rules and preceding other provisions concerning reductions in provider payments. In addition, to ensure that these provisions apply to contracts that States use to provide Medicaid benefits using a managed care delivery system, we proposed to modify the regulations at 42 CFR part 438.</P>
          <P>Currently, the general rules regarding Medicaid State plan payments for Medicaid are provided at part 447 subpart A. We proposed to add a new § 447.26 to indicate that FFP will not be available for expenditures made for PPCs. We have included in § 447.26(a) a statement of the basis and purpose for the regulation, and in § 447.26(b), the definitions for the umbrella term PPCs, and the included terms HCACs, and other PPCs. We proposed to establish Medicare as the floor that all States must adopt, but allow flexibility for States to move beyond the Medicare definitions and settings. As States' programs evolve and they make additional requirements, we will require that necessary SPAs be submitted for implementation purposes.</P>
          <P>In § 447.26(c), we proposed to set forth the general rule that State plans must preclude payment to providers for PPCs, and that FFP is not available for State expenditures for PPCs. To ensure beneficiary access to care, we specified that any reductions may be limited to the added cost resulting from the PPC.</P>
          <P>In § 447.26(d), we have included a provision that will require States to require provider reporting of PPCs associated with Medicaid claims, or with courses of treatment for Medicaid beneficiaries that would otherwise be payable under Medicaid.</P>
          <P>In addition to these changes in part 447, we proposed including a requirement in § 434.6(a)(12) for contracts for medical or administrative services that contractors do not make payment for PPCs, and require that providers comply with the reporting requirements in § 447.26(d) as a condition of receiving payment. Likewise, to ensure that these provisions are included as required elements in Medicaid managed care contracts, we proposed including a requirement in § 438.6(f)(2) that contracts must comply with both § 434.6(a)(12) and § 447.26.</P>
          <P>We proposed these particular provisions because the information gathered in preparation for issuing the proposed rule indicated the need for a consistent authority under which States could implement PPC nonpayment policies; a consistent approach to identifying conditions for nonpayment; a streamlined terminology to indicate Medicaid HCAC payment policies; State flexibility to implement provisions suitable to their own systems; and a consistent provider reporting platform.</P>
          <P>We received the following comments in response to our proposals to revise the regulations text.</P>
          <P>
            <E T="03">Comment:</E>One commenter believed that the language of the proposed regulation could be construed to limit payments even when the PPC condition was present on admission or initiation of provider treatment.</P>
          <P>
            <E T="03">Response:</E>The language in the proposed regulation was intended to cover only situations where payment reduction was being applied to treatment for a condition not present on admission or commencement of treatment by that provider. However, we understand that clarifying the language of the regulation to emphasize this point would be helpful to and we have done so in this final rule. New § 447.26(c)(3) language explicitly states that “* * * no reduction in payment for a PPC will be imposed on a provider when the condition defined as a PPC for a particular patient existed prior to the initiation of treatment for that patient by that provider.” This was implied in the previous language, but has now been made explicit. We agree with the comment and are providing this clarification.</P>
          <P>
            <E T="03">Comment:</E>A number of commenters requested that CMS clarify that the HCAC category applies only to inpatient hospitals.</P>
          <P>
            <E T="03">Response:</E>The final rule has revised regulatory language to clarify that HCAC category applies to all Medicaid inpatient hospital settings.</P>
          <P>
            <E T="03">Comment:</E>One commenter expressed concern that expansion of PPC to nonhospital providers threatened the access of Medicaid beneficiaries to care. In particular, commenters asked CMS to clarify that Medicaid payment disallowance for PPC would not apply when the PPC was present at the time the provider commenced treatment of the patient.</P>
          <P>
            <E T="03">Response:</E>The language in the proposed regulation was intended to cover only situations where payment reduction was being applied to treatment for a condition not present on admission or commencement of treatment by that provider. However, we understand that clarifying the language of the regulation to emphasize this point would be helpful and we have done so in this final rule. New § 447.26(c)(2) language explicitly states that “* * * no reduction in payment for a PPC will be imposed on a provider when the condition defined as a PPC for a particular patient existed prior to the initiation of treatment for that patient by that provider.” This was implied in the previous language, but has now been made explicit. CMS agrees with the comment and is providing this clarification.</P>
          <P>
            <E T="03">Comment:</E>A few commenters believed that the distinctions among the terms in the proposed rule were confusing and made it hard to understand which term applied to which criteria.</P>
          <P>
            <E T="03">Response:</E>We have revised the regulatory text to make it clear that provider preventable conditions are clearly defined into two separate categories, healthcare acquired conditions (Medicare's HACs applicable only to inpatient hospital providers paid under the IPPS) and other provider-preventable conditions (conditions minimally defined as Medicare's 3 NCDs, applicable in any healthcare service setting).</P>
          <P>
            <E T="03">Comment:</E>One commenter requested clarification on the purpose of provider reporting and how CMS expects States to use reported information. Another commenter noted that there is no clear provision on how States are to report this data to CMS. One State questioned whether the SPA will have to specify how the reporting will be done, or if States will need to assure that they will comply with the requirement.</P>
          <P>
            <E T="03">Response:</E>We are requiring that States impose provider self-reporting through claims systems because that information will be fed by States to CMS. CMS and States will use this data to inform policy making. Language assuring compliance with this provision is incorporated in the State plan pre-print associated with this provision.</P>
          <P>
            <E T="03">Comment:</E>One commenter supports nonpayment for all PPCs as they pertain to the dual eligible population. This<PRTPAGE P="32833"/>commenter urges CMS to codify provisions that prohibit Medicaid claim payment for claims that have been denied by Medicare based on the presence of a HAC.</P>
          <P>
            <E T="03">Response:</E>This is a significant area of concern, and we have revised the final regulation to clarify the prohibition on Medicaid payment for claims that have been denied (in full or in part) by Medicare, to reflect this recommendation.</P>
          <P>
            <E T="03">Comment:</E>One commenter noted that the proposed rule requires States to establish a provider reporting requirement for PPCs and requested that amend the final rule to allow States time to implement the PPC policies in general.</P>
          <P>
            <E T="03">Response:</E>As a requirement of the final rule, States will implement the provider self-reporting through payment claims systems regardless of the provider's intention to bill. We anticipate that States and providers, especially those groups of providers that have not been subject to Medicare's HAC policy, will need to work collaboratively to develop and implement reporting systems that would complement existing payment structures.</P>
          <HD SOURCE="HD1">III. Provisions of the Final Rule</HD>
          <P>This final rule incorporates the provisions of the proposed rule with the following exceptions.</P>
          <P>In § 447.26(b), we are revising the definition of health care-acquired condition to mean a condition occurring in any inpatient hospital setting, identified as a HAC by the Secretary under section 1886(d)(4)(D)(iv) of the Act for purposes of the Medicare program identified in the State plan as described in section 1886(d)(4)(D)(ii) and (iv) of the Act; other than Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) related to total knee replacement or hip replacement surgery in pediatric and/or obstetric patients.</P>
          <P>In § 447.26(c)(1), we are revising the language to read “A State plan must provide that no medical assistance will be paid for “provider-preventable conditions” as defined in this section; and as applicable for individuals dually eligible for both the Medicare and Medicaid programs.”</P>
          <HD SOURCE="HD1">IV. Collection of Information Requirements</HD>

          <P>Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the<E T="04">Federal Register</E>and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:</P>
          <P>• The need for the information collection and its usefulness in carrying out the proper functions of our agency.</P>
          <P>• The accuracy of our estimate of the information collection burden.</P>
          <P>• The quality, utility, and clarity of the information to be collected.</P>
          <P>• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.</P>
          <P>In accordance with the Act, we solicited public comments on the proposed collection of information, with a 30-day comment period, in the proposed rule that published on February 17, 2011 (76 FR 9283). We did not receive any substantive comments related to the proposed information collection requirements or burdens and, therefore, we are retaining the following requirements and estimates that were set out in the proposed rule.</P>
          <HD SOURCE="HD2">A. ICRs Regarding Contract Requirements (§ 438.6)</HD>
          <P>Section 438.6(f)(2) will also require States which provide medical assistance using a managed care delivery system to modify their managed care contracts to reflect the PPCs payment adjustment policies as applied through these regulations. The burden associated with this requirement is the time and effort necessary for a State to amend its managed care contracts to reflect these policies. We estimated that 48 States will be required to comply with this requirement. We also estimated that it will take 8 hours for each State to revise its contracts to comply with this requirement and submit the amended contract to CMS for review and approval. The total estimated annual burden associated with this requirement is 384 hours at a cost of $20.67 per hour per State.</P>
          <HD SOURCE="HD2">B. ICRs Regarding the Prohibition on Payment for Provider-Preventable Conditions (§ 447.26)</HD>
          <P>Effective July 1, 2011, § Section 447.26(c)(1) will require States to submit SPAs for CMS approval that would reduce payments to providers by amounts related to PPCs. The burden associated with this requirement will be the time and effort necessary for a State to submit its SPA and the associated pre-print. We estimated that 50 States, the District of Columbia, and Territories will be required to comply with this requirement. We further estimated that it will take each State 7 hours to submit the aforementioned documentation to CMS. The total estimated burden associated with this requirement would be 385 hours at a cost of $20.67 per hour per State.</P>
          <P>We estimated that it will take each State 7 hours because we intend to issue a template to States to simplify the process of making the related amendment to the Medicaid State plan.</P>
          <P>Section 447.26(c)(2) will also require States to implement provider reporting requirements to ensure that PPCs are identified in claims for Medicaid payment. The burden associated with this requirement is the time and effort necessary to develop and implement provider reporting requirements that are effective with the provisions of this regulation. We estimated that 50 States, the District of Columbia, and Territories will be required to comply with this requirement. We estimated that it will take 24 hours for each State to develop and implement the provider reporting requirements as specified above. The total estimated burden associated with this requirement will be 1320 hours at a cost of $20.67 per hour per State. We believe that this estimate is reasonable because we are requiring that States have providers use their existing claims processes to report identified events.</P>
          
          <PRTPAGE P="32834"/>
          <GPOTABLE CDEF="s30,xs48,11,9,9,9,9,7.2,11,7.2" COLS="10" OPTS="L2,p7,7/8,i1">
            <TTITLE>Table 1—Annual Recordkeeping and Reporting Requirements</TTITLE>
            <BOXHD>
              <CHED H="1">Regulation section(s)</CHED>
              <CHED H="1">OMB<LI>Control</LI>
                <LI>No.</LI>
              </CHED>
              <CHED H="1">Number of<LI>respondents</LI>
              </CHED>
              <CHED H="1">Number of<LI>responses</LI>
              </CHED>
              <CHED H="1">Burden<LI>per</LI>
                <LI>response</LI>
                <LI>(hours)</LI>
              </CHED>
              <CHED H="1">Total<LI>annual</LI>
                <LI>burden</LI>
                <LI>(hours)</LI>
              </CHED>
              <CHED H="1">Hourly labor<LI>cost of</LI>
                <LI>reporting</LI>
                <LI>($)</LI>
              </CHED>
              <CHED H="1">Total labor<LI>cost of</LI>
                <LI>reporting</LI>
                <LI>($)</LI>
              </CHED>
              <CHED H="1">Total<LI>capital/</LI>
                <LI>maintenance</LI>
                <LI>costs</LI>
                <LI>($)</LI>
              </CHED>
              <CHED H="1">Total cost<LI>($)</LI>
              </CHED>
            </BOXHD>
            <ROW>
              <ENT I="01">438.6(f)(2)</ENT>
              <ENT>0938-NEW</ENT>
              <ENT>48</ENT>
              <ENT>48</ENT>
              <ENT>8</ENT>
              <ENT>384</ENT>
              <ENT>20.67</ENT>
              <ENT>7,937.28</ENT>
              <ENT>0</ENT>
              <ENT>7,937.28</ENT>
            </ROW>
            <ROW>
              <ENT I="01">447.26(c)(1)</ENT>
              <ENT>0938-NEW</ENT>
              <ENT>55</ENT>
              <ENT>55</ENT>
              <ENT>7</ENT>
              <ENT>385</ENT>
              <ENT>20.67</ENT>
              <ENT>7957.95</ENT>
              <ENT>0</ENT>
              <ENT>7,957.5</ENT>
            </ROW>
            <ROW RUL="n,s">
              <ENT I="01">447.26(c)(2)</ENT>
              <ENT>0938-NEW</ENT>
              <ENT>55</ENT>
              <ENT>55</ENT>
              <ENT>24</ENT>
              <ENT>1,320</ENT>
              <ENT>20.67</ENT>
              <ENT>27,284.4</ENT>
              <ENT>0</ENT>
              <ENT>27,284.4</ENT>
            </ROW>
            <ROW>
              <ENT I="03">Total</ENT>
              <ENT/>
              <ENT>158</ENT>
              <ENT>158</ENT>
              <ENT>39</ENT>
              <ENT>2089</ENT>
              <ENT/>
              <ENT/>
              <ENT>0</ENT>
              <ENT>43,179.18</ENT>
            </ROW>
          </GPOTABLE>
          <P>The estimated annual burden associated with the requirements under 438.6(f)(2), 447.26(c)(1), and 447.26(c)(2) is 2,089 hours (total) at a cost of $43,179.18 (total) or $806.13 (per State).</P>
          <GPOTABLE CDEF="s30,xs48,11,9,9,9,9,7.2,11,7.2" COLS="10" OPTS="L2,p7,7/8,i1">
            <TTITLE>Table 2—Annual Recordkeeping and Reporting Requirements</TTITLE>
            <BOXHD>
              <CHED H="1">Regulation section(s)</CHED>
              <CHED H="1">OMB<LI>Control</LI>
                <LI>No.</LI>
              </CHED>
              <CHED H="1">Number of<LI>respondents</LI>
              </CHED>
              <CHED H="1">Number of<LI>responses</LI>
              </CHED>
              <CHED H="1">Burden<LI>per</LI>
                <LI>response</LI>
                <LI>(hours)</LI>
              </CHED>
              <CHED H="1">Total<LI>annual</LI>
                <LI>burden</LI>
                <LI>(hours)</LI>
              </CHED>
              <CHED H="1">Hourly labor<LI>cost of</LI>
                <LI>reporting</LI>
                <LI>($)</LI>
              </CHED>
              <CHED H="1">Total labor<LI>cost of</LI>
                <LI>reporting</LI>
                <LI>($)</LI>
              </CHED>
              <CHED H="1">Total<LI>capital/</LI>
                <LI>maintenance</LI>
                <LI>costs</LI>
                <LI>($)</LI>
              </CHED>
              <CHED H="1">Total cost<LI>($)</LI>
              </CHED>
            </BOXHD>
            <ROW>
              <ENT I="01">438.6(f)(2)</ENT>
              <ENT>0938-NEW</ENT>
              <ENT>48</ENT>
              <ENT>48</ENT>
              <ENT>8</ENT>
              <ENT>384</ENT>
              <ENT>20.67</ENT>
              <ENT>7,937.28</ENT>
              <ENT>0</ENT>
              <ENT>7,937.28</ENT>
            </ROW>
            <ROW>
              <ENT I="01">447.26(c)(1)</ENT>
              <ENT>0938-NEW</ENT>
              <ENT>50</ENT>
              <ENT>50</ENT>
              <ENT>7</ENT>
              <ENT>350</ENT>
              <ENT>20.67</ENT>
              <ENT>7,234.5</ENT>
              <ENT>0</ENT>
              <ENT>7,234.5</ENT>
            </ROW>
            <ROW RUL="n,s">
              <ENT I="01">447.26(c)(2)</ENT>
              <ENT>0938-NEW</ENT>
              <ENT>50</ENT>
              <ENT>50</ENT>
              <ENT>24</ENT>
              <ENT>1,200</ENT>
              <ENT>20.67</ENT>
              <ENT>2,4804</ENT>
              <ENT>0</ENT>
              <ENT>2,4804</ENT>
            </ROW>
            <ROW>
              <ENT I="03">Total</ENT>
              <ENT/>
              <ENT>98</ENT>
              <ENT>148</ENT>
              <ENT>39</ENT>
              <ENT>1,934</ENT>
              <ENT/>
              <ENT/>
              <ENT>0</ENT>
              <ENT>39,975.78</ENT>
            </ROW>
          </GPOTABLE>
          <P>The estimated annual burden associated with the requirements under 438.6(f)(2), 447.26(c)(1), and 447.26(c)(2) is 1,934 hours (total) at a cost of $39,975.78 (total) or $806.13 (per State).</P>
          <P>To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on July 7, 2011.</P>
          <P>OMB, Office of Information and Regulatory Affairs,<E T="03">Attention:</E>CMS Desk Officer,<E T="03">Fax Number:</E>(202) 395-5806.<E T="03">Fax Number:</E>(202) 395-6974.</P>
          <HD SOURCE="HD1">V. Regulatory Impact Statement</HD>
          <HD SOURCE="HD2">A. Statement of Need</HD>
          <P>This final rule implements section 2702 of the Affordable Care Act which directs the Secretary to issue Medicaid regulations effective as of July 2011, prohibiting Federal payments to States (under section 1903 of the Act) for any amounts expended for providing medical assistance for HCACs. It will also authorize States to identify other PPCs for which Medicaid payment would be prohibited. We view this regulation as one step of a larger approach to address the problem of PPCs.</P>
          <HD SOURCE="HD2">B. Overall Impact</HD>
          <P>We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).</P>
          <P>Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule under the Congressional Review Act.</P>

          <P>It is difficult to estimate the amount which will be withheld from providers under this regulation, as not all of these events will be billed. However, it is instructive to note that the total dollar amount of Medicare claims denied under its HAC policy is approximately $20 million per year (see 75 FR 23895, May 4, 2010). The original regulation creating the Medicare HACs was published in the August 19, 2008<E T="04">Federal Register</E>(73 FR 48433). In addition, estimates were conducted by the Congressional Budget Office (CBO) and the CMS Office of the Actuary (OACT) on the impact of section 2702 of the Affordable Care Act. The CBO estimate concluded there would be no impact associated with section 2702 of the Affordable Care Act (CBO and JCT, 2010 Estimate). The CMS OACT estimate (Estimated Financial Effects of the “Patient Protection and Affordable Care Act,” as Amended, 2010) projected an impact from section 2702 of the Affordable Care Act on the Medicaid program of cost savings of $2 million for FY 2011 ($1 million for the Federal share and $1 million for the State share), with an aggregate cost savings of $35 million ($20 million for the Federal share and $15 million for the State share) for FYs 2011 through 2015. The Federal and State share cost savings, as result of denied payments, are represented by the reduction in transfers from Medicaid to hospitals. These estimates could be higher if States elect to expand beyond the minimum requirements of this rule.<PRTPAGE P="32835"/>
          </P>
          <GPOTABLE CDEF="s50,12,12,12,12,12,12" COLS="7" OPTS="L2,i1">
            <TTITLE>Table 3—Medicaid Impacts for FYs 2011 Through 2015</TTITLE>
            <BOXHD>
              <CHED H="1">Medicaid impacts</CHED>
              <CHED H="1">FY impact ($ millions)</CHED>
              <CHED H="2">2011</CHED>
              <CHED H="2">2012</CHED>
              <CHED H="2">2013</CHED>
              <CHED H="2">2014</CHED>
              <CHED H="2">2015</CHED>
              <CHED H="2">Total</CHED>
            </BOXHD>
            <ROW>
              <ENT I="01">Federal Share</ENT>
              <ENT>−1</ENT>
              <ENT>−4</ENT>
              <ENT>−5</ENT>
              <ENT>−5</ENT>
              <ENT>−5</ENT>
              <ENT>−20</ENT>
            </ROW>
            <ROW RUL="n,s">
              <ENT I="01">State Share</ENT>
              <ENT>−1</ENT>
              <ENT>−3</ENT>
              <ENT>−3</ENT>
              <ENT>−4</ENT>
              <ENT>−4</ENT>
              <ENT>−15</ENT>
            </ROW>
            <ROW>
              <ENT I="03">Total</ENT>
              <ENT>−2</ENT>
              <ENT>−7</ENT>
              <ENT>−8</ENT>
              <ENT>−9</ENT>
              <ENT>−9</ENT>
              <ENT>−35</ENT>
            </ROW>
          </GPOTABLE>
          <P>There are administrative cost impacts on States to modify their systems to meet reporting requirements, but we believe these are not significant. As noted above, the reporting system in this final rule relies on an existing billing system currently in place. Both States and providers already have billing, claiming, and payment systems in place to act upon the information obtained. The costs reported in section IV of this final rule, Collection of Information Requirements, amount to an additional $39,976 dollars aggregate across all States.</P>
          <P>Hospitals may incur additional costs to reduce PPCs. Such costs include hiring additional nurses to ensure enforcement of the infection prevention policies. In turn, preventing or reducing HCACs will lead to a reduction in direct health spending, which is a benefit realized by Medicaid, hospitals and other payers.</P>
          <P>The Joint Commission requires hospitals to have established programs for Quality Improvement, Risk Management, Safety, and Infection Control. As a result, a majority of hospitals already have in place programs to avert Medicare HACs and thus would not incur new costs to implement parallel programs to avert Medicaid HCACs. Furthermore, we anticipate a public benefit to all providers and payers since programs that hospitals develop to avoid Medicaid HCACs will likely benefit all patients and reduce health care costs. Patient benefits resulting from a reduction in HCAC may include an increase in healthy years of life. However, this public benefit will derive from possible responses by hospitals and not from this regulation itself.</P>
          <P>We realize that the overall problem of HCACs cannot be completely addressed in this regulation, as this final regulation is one step of an overall approach. Consequently, the estimated economic impacts from all HHS initiatives to address HCACs may result in much higher savings impact than presented in this analysis. However, such economic savings, for example, will not derive from this regulation alone, but will in part come from the knowledge that State and Federal governments gain from the reporting requirements created by this regulation. That knowledge will in turn inform future HHS initiatives to reduce excess morbidity and mortality attributable to PPCs.</P>
          <P>The RFA requires agencies to analyze options for regulatory relief for small entities, if a rule has a significant impact on a substantial number of small entities. Most hospitals, other providers, and suppliers are small entities, either by nonprofit status or by having revenues of $7.0 million to $34.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. Guidance issued by the Department of Health and Human Services interpreting the RFA considers effects to be economically significant if they reach a threshold of 3 to 5 percent or more of total revenue or total costs. As illustrated in Table 1, any decrease in payments, as a result of this regulation, to small entities should be significantly less than this threshold. Therefore, we are not preparing an analysis for the RFA because the Secretary has determined that this final rule will not have a significant economic impact on a substantial number of small entities.</P>
          <P>In addition, section 1102(b) of the Act requires us to prepare a RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because the Secretary has determined that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals.</P>
          <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. This rule will have no consequential effect on State, local, or tribal governments in the aggregate or on the private sector.</P>
          <P>Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. While this regulation does not impose substantial costs on State or local governments, it does preempt some State laws. The requirements of Executive Order 13132 are applicable.</P>
          <P>Executive Order 13132 sets forth a process to be followed by the Federal government whenever Federal regulatory processes may affect or preempt State regulations or laws. We are aware that many States do have regulations for Medicaid nonpayment in the event that specified adverse events occur during provider care. This final rule is intended to create a Federal legal minimum for such State regulations. States could continue to enact more stringent laws or regulations upon approval of a Medicaid SPA by CMS to assure that there is no adverse impact on Medicaid beneficiary access to care.</P>
          <P>This final rule derives from section 2702 of the Affordable Care Act and other CMS statutory authority. Under the requirements of Executive Order 13132 and the requirements of section 2702 of the Affordable Care Act, we have consulted with the States before issuing this final rule. Major portions of the regulation are, in fact, derived from comparable State regulations. Significant regulatory authority in this area would remain with the States should the proposed regulation become final. As stated, the final rule does not completely preempt State law, but merely sets a Federal minimum standard.</P>

          <P>We are meeting the requirements of Executive Order 13132 by issuing this final rule 30 days prior to the effective<PRTPAGE P="32836"/>date of July 1, 2011, set forth in the Affordable Care Act.</P>
          <HD SOURCE="HD2">C. Anticipated Effects</HD>
          <HD SOURCE="HD3">1. Effects on State Medicaid Programs</HD>
          <P>The effects on State Medicaid programs as a result of this provision will depend on various factors. For instance, as we state in the preamble, there are 21 States that have already implemented similar policies. While we have reviewed existing State policies and incorporated those policies that we believe would best apply on a national level, these States will have to make changes to comply with the minimums set in this final rule. In addition, States will have to work through the SPA review process to ensure that their existing policies do not serve to limit beneficiaries' access to healthcare.</P>
          <P>The States that have used State plan authority to implement their nonpayment policies will need to review their policies and ensure that they comply with any final provisions of these rules. These States will likely have to submit revisions to their State plans. In addition, the States that implemented these policies through some other authority like State law or administrative procedures will have to submit new SPAs for review and work with CMS to ensure that their policies effective July 1, 2011, are in line with the final provisions of these rules. States that have elected not to implement Medicaid specific policies or that do not have related policies at all will need to submit new SPAs. Further, States which use a managed care delivery system to provide Medicaid benefits to beneficiaries will have to amend and submit for CMS review and approval managed care contracts that reflect these new requirements. While this regulation is effective on July 1, 2011, most States will already have their managed care contracts for the fiscal year in place by that time and there may be some delay in incorporating new language in their managed care contracts. We will issue subregulatory guidance to States requiring that appropriate changes be made to managed care contracts to comply with the regulation.</P>
          <P>All States will need to incorporate the reporting requirements into their claims systems. In addition, States will need to evaluate the best ways in which to identify and reduce payment for PPCs under their respective Medicaid plans.</P>
          <P>We anticipate that this provision will prompt programmatic changes for States regarding quality improvement considerations within health care systems. This provision, while it is a payment provision, is primarily targeted at preventing medical errors.</P>
          <HD SOURCE="HD3">2. Effects on Other Providers</HD>
          <P>We anticipate that these provisions will prompt health care providers to adopt quality programs that would limit the risk of providing services or using resources, in error, that will not be reimbursed.</P>
          <P>We anticipate that the reporting requirements will ultimately be a catalyst for providers in developing quality practices to reduce the risks associated with receiving care at their facilities and promote overall quality improvements.</P>
          <HD SOURCE="HD3">3. Effects on the Medicaid Program</HD>
          <P>Medicare's and States' experience has demonstrated that related policies often do not produce substantial short-term financial savings within health care systems. Medicare estimated that the policy will reduce its spending by an aggregate amount of about $80,000,000 from FY 2009 through FY 2013, or by less than 0.01 percent of total annual spending on inpatient hospital services (75 FR 50661). States report similar short-term savings. However, there are more significant gains to be realized when considering the broader impact of increased quality on the health system overall, or more exactly the savings created when preventable conditions and related treatment are measured.</P>
          <P>The anticipated public benefit to all providers and payers from programs that hospitals develop to avoid Medicaid HCACs will likely benefit all patients and reduce health care costs. This includes, for example, Medicaid beneficiaries realizing an increase in healthy years of life as a result of the reduction in HCACs. However, this public benefit will derive from possible responses by hospitals and not from this regulation itself.</P>
          <HD SOURCE="HD2">D. Alternatives Considered: Conditions Identified as Provider-Preventable Conditions</HD>
          <P>The statute requires that Medicaid, at a minimum, recognize Medicare's current list of HACs. We considered proposing regulatory action that included only the conditions listed as Medicare HACs. However, when considering current State practices our research concluded that many States' policies included conditions not identified by Medicare as HACs. We concluded that such limited action would not serve the program purposes of ensuring high quality care and would potentially limit State flexibility to protect beneficiaries and program integrity. Similarly, we considered proposing regulatory action that included only the inpatient hospital setting. Again, after assessing current State practices, as well as industry-based research, there is clear indication that data is available to States that will allow them to employ evidence based policy practices beyond the inpatient hospital setting. To provide States full flexibility to protect beneficiaries and the program, we elected the more comprehensive approach that we discussed in the proposed rule. We considered defining OPPC as, “a condition occurring in any health care setting that could have reasonably been prevented through the ordinary provision of high quality care during the course of treatment * * *” We believed that this terminology would limit additional requirements on States to produce evidence of preventability. However, after discussing the terminology and scientific parameters that exist in relation to this issue, we proposed that the term be defined as, “a condition that could have reasonably been prevented through the application of evidence based guidelines.”</P>
          <HD SOURCE="HD2">E. Conclusion</HD>
          <P>For the reasons outlined in the RIA, we are not preparing an analysis for either the RFA or section 1102(b) of the Act because we have determined that this final rule would not have a direct significant economic impact on a substantial number of small entities or a direct significant impact on the operations of a substantial number of small rural hospitals.</P>
          <P>In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.</P>
          <LSTSUB>
            <HD SOURCE="HED">List of Subjects</HD>
            <CFR>42 CFR Part 434</CFR>
            <P>Grant programs—health, Health maintenance organizations (HMO), Medicaid, Reporting and recordkeeping requirements.</P>
            <CFR>42 CFR Part 438</CFR>
            <P>Grant programs—health, Medicaid, Reporting and recordkeeping requirements.</P>
            <CFR>42 CFR Part 447</CFR>
            <P>Accounting, Administrative practice and procedure, Drugs, Grant programs—health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas.</P>
          </LSTSUB>
          <P>For the reasons set forth in the preamble, the Centers for Medicare &amp; Medicaid Services amends 42 CFR parts 434, 438, and 447, as set forth below:</P>
          <REGTEXT PART="434" TITLE="42">
            <PART>
              <PRTPAGE P="32837"/>
              <HD SOURCE="HED">PART 434—CONTRACTS</HD>
            </PART>
            <AMDPAR>1. The authority citation for part 434 continues to read as follows:</AMDPAR>
            <AUTH>
              <HD SOURCE="HED">Authority:</HD>
              <P>Sec. 1102 of the Social Security Act (42 U.S.C. 1302).</P>
            </AUTH>
          </REGTEXT>
          <REGTEXT PART="434" TITLE="42">
            <SUBPART>
              <HD SOURCE="HED">Subpart A—General Provisions</HD>
            </SUBPART>
            <AMDPAR>2. Section 434.6 is amended by—</AMDPAR>
            <AMDPAR>A. Revising the introductory text of paragraph (a).</AMDPAR>
            <AMDPAR>B. Removing the semicolons from the end of paragraphs (a)(1) through (a)(9), and the semicolon and the word “and” from the end of paragraph (a)(10) and replacing them with a period.</AMDPAR>
            <AMDPAR>C. Adding a new paragraph (a)(12).</AMDPAR>
            <P>The revision and addition read as follows:</P>
            <SECTION>
              <SECTNO>§ 434.6</SECTNO>
              <SUBJECT>General requirements for all contracts and subcontracts.</SUBJECT>
              <P>(a)<E T="03">Contracts.</E>All contracts under this part must include all of the following:</P>
              <P>* * *</P>
              <P>(12) Specify the following:</P>
              <P>(i) No payment will be made by the contractor to a provider for provider-preventable conditions, as identified in the State plan.</P>
              <P>(ii) The contractor will require that all providers agree to comply with the reporting requirements in § 447.26(d) of this subchapter as a condition of payment from the contractor.</P>
              <P>(iii) The contractor will comply with such reporting requirements to the extent the contractor directly furnishes services.</P>
              <STARS/>
            </SECTION>
          </REGTEXT>
          <REGTEXT PART="438" TITLE="42">
            <PART>
              <HD SOURCE="HED">PART 438—MANAGED CARE</HD>
            </PART>
            <AMDPAR>3. The authority citation for part 438 continues to read as follows:</AMDPAR>
            <AUTH>
              <HD SOURCE="HED">Authority:</HD>
              <P>Sec. 1102 of the Social Security Act (42 U.S.C. 1302).</P>
            </AUTH>
          </REGTEXT>
          <REGTEXT PART="438" TITLE="42">
            <SUBPART>
              <HD SOURCE="HED">Subpart A—General Provisions</HD>
            </SUBPART>
            <AMDPAR>4. Section 438.6 is amended by revising paragraph (f) to read as follows:</AMDPAR>
            <SECTION>
              <SECTNO>§ 438.6</SECTNO>
              <SUBJECT>Contract requirements.</SUBJECT>
              <STARS/>
              <P>(f)<E T="03">Compliance with contracting rules.</E>All contracts must meet the following provisions:</P>
              <P>(1) Comply with all applicable Federal and State laws and regulations including title VI of the Civil Rights Act of 1964; title IX of the Education Amendments of 1972 (regarding education programs and activities); the Age Discrimination Act of 1975; the Rehabilitation Act of 1973; and the Americans with Disabilities Act of 1990 as amended.</P>
              <P>(2) Provide for the following:</P>
              <P>(i) Compliance with the requirements mandating provider identification of provider-preventable conditions as a condition of payment, as well as the prohibition against payment for provider-preventable conditions as set forth in § 434.6(a)(12) and § 447.26 of this subchapter.</P>
              <P>(ii) Reporting all identified provider-preventable conditions in a form or frequency as may be specified by the State.</P>
              <P>(3) Meet all the requirements of this section.</P>
              <STARS/>
            </SECTION>
          </REGTEXT>
          <REGTEXT PART="447" TITLE="42">
            <PART>
              <HD SOURCE="HED">PART 447—PAYMENTS FOR SERVICES</HD>
            </PART>
            <AMDPAR>5. The authority citation for part 447 continues to read as follows:</AMDPAR>
            <AUTH>
              <HD SOURCE="HED">Authority:</HD>
              <P>Sec. 1102 of the Social Security Act (42 U.S.C. 1302).</P>
            </AUTH>
          </REGTEXT>
          <REGTEXT PART="447" TITLE="42">
            <SUBPART>
              <HD SOURCE="HED">Subpart A—Payments: General Provisions</HD>
            </SUBPART>
            <AMDPAR>6. Section 447.26 is added to read as follows:</AMDPAR>
            <SECTION>
              <SECTNO>§ 447.26</SECTNO>
              <SUBJECT>Prohibition on payment for provider-preventable conditions.</SUBJECT>
              <P>(a)<E T="03">Basis and purpose.</E>The purpose of this section is to protect Medicaid beneficiaries and the Medicaid program by prohibiting payments by States for services related to provider-preventable conditions.</P>
              <P>(1) Section 2702 of the Affordable Care Act requires that the Secretary exercise authority to prohibit Federal payment for certain provider preventable conditions (PPCs) and health care-acquired conditions (HCACs).</P>
              <P>(2) Section 1902(a)(19) of the Act requires that States provide care and services consistent with the best interests of the recipients.</P>
              <P>(3) Section 1902(a)(30) of the Act requires that State payment methods must be consistent with efficiency, economy, and quality of care.</P>
              <P>(b)<E T="03">Definitions.</E>As used in this section—</P>
              <P>
                <E T="03">Health care-acquired condition</E>means a condition occurring in any inpatient hospital setting, identified as a HAC by the Secretary under section 1886(d)(4)(D)(iv) of the Act for purposes of the Medicare program identified in the State plan as described in section 1886(d)(4)(D)(ii) and (iv) of the Act; other than Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) as related to total knee replacement or hip replacement surgery in pediatric and obstetric patients.</P>
              <P>
                <E T="03">Other provider-preventable condition</E>means a condition occurring in any health care setting that meets the following criteria:</P>
              <P>(i) Is identified in the State plan.</P>
              <P>(ii) Has been found by the State, based upon a review of medical literature by qualified professionals, to be reasonably preventable through the application of procedures supported by evidence-based guidelines.</P>
              <P>(iii) Has a negative consequence for the beneficiary.</P>
              <P>(iv) Is auditable.</P>
              <P>(v) Includes, at a minimum, wrong surgical or other invasive procedure performed on a patient; surgical or other invasive procedure performed on the wrong body part; surgical or other invasive procedure performed on the wrong patient.</P>
              <P>
                <E T="03">Provider-preventable condition</E>means a condition that meets the definition of a “health care-acquired condition” or an “other provider-preventable condition” as defined in this section.</P>
              <P>(c)<E T="03">General rules.</E>
              </P>
              <P>(1) A State plan must provide that no medical assistance will be paid for “provider-preventable conditions” as defined in this section; and as applicable for individuals dually eligible for both the Medicare and Medicaid programs.</P>
              <P>(2) No reduction in payment for a provider preventable condition will be imposed on a provider when the condition defined as a PPC for a particular patient existed prior to the initiation of treatment for that patient by that provider.</P>
              <P>(3) Reductions in provider payment may be limited to the extent that the following apply:</P>
              <P>(i) The identified provider-preventable conditions would otherwise result in an increase in payment.</P>
              <P>(ii) The State can reasonably isolate for nonpayment the portion of the payment directly related to treatment for, and related to, the provider-preventable conditions.</P>
              <P>(4) FFP will not be available for any State expenditure for provider-preventable conditions.</P>
              <P>(5) A State plan must ensure that non-payment for provider-preventable conditions does not prevent access to services for Medicaid beneficiaries.</P>
              <P>(d)<E T="03">Reporting.</E>State plans must require that providers identify provider-preventable conditions that are associated with claims for Medicaid payment or with courses of treatment furnished to Medicaid patients for which Medicaid payment would otherwise be available.</P>
            </SECTION>
          </REGTEXT>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>(Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program)</P>
          </AUTH>
          <SIG>
            <PRTPAGE P="32838"/>
            <DATED>Dated: May 25, 2011.</DATED>
            <NAME>Donald M. Berwick,</NAME>
            <TITLE>Administrator, Centers for Medicare &amp; Medicaid Services.</TITLE>
            <DATED>Approved: May 27, 2011.</DATED>
            <NAME>Kathleen Sebelius,</NAME>
            <TITLE>Secretary, Department of Health and Human Services.</TITLE>
          </SIG>
        </SUPLINF>
        <FRDOC>[FR Doc. 2011-13819 Filed 6-1-11; 11:15 am]</FRDOC>
        <BILCOD>BILLING CODE 4120-01-P</BILCOD>
      </RULE>
    </RULES>
  </NEWPART>
  <VOL>76</VOL>
  <NO>108</NO>
  <DATE>Monday, June 6, 2011</DATE>
  <UNITNAME>Rules and Regulations</UNITNAME>
  <NEWPART>
    <PTITLE>
      <PRTPAGE P="32839"/>
      <PARTNO>Part IV</PARTNO>
      <AGENCY TYPE="P">Department of Defense</AGENCY>
      <SUBAGY>Defense Acquisition Regulations System</SUBAGY>
      <HRULE/>
      <CFR>48 CFR Parts 203, 204, 225,<E T="03">et al.</E>
      </CFR>
      <TITLE>Defense Federal Acquisition Regulation Supplements; Final Rules and Proposed Rules</TITLE>
    </PTITLE>
    <RULES>
      <RULE>
        <PREAMB>
          <PRTPAGE P="32840"/>
          <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
          <SUBAGY>Defense Acquisition Regulations System</SUBAGY>
          <CFR>48 CFR Parts 203 and 252</CFR>
          <RIN>RIN 0750-AG97</RIN>
          <SUBJECT>Defense Federal Acquisition Regulation Supplement; Agency Office of the Inspector General (DFARS Case 2011-D006)</SUBJECT>
          <AGY>
            <HD SOURCE="HED">AGENCY:</HD>
            <P>Defense Acquisition Regulations System, Department of Defense (DoD).</P>
          </AGY>
          <ACT>
            <HD SOURCE="HED">ACTION:</HD>
            <P>Final rule.</P>
          </ACT>
          <SUM>
            <HD SOURCE="HED">SUMMARY:</HD>
            <P>DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to make some administrative corrections relating to DFARS clause 252.203-7003, Agency Office of the Inspector General.</P>
          </SUM>
          <EFFDATE>
            <HD SOURCE="HED">DATES:</HD>
            <P>
              <E T="03">Effective Date:</E>June 6, 2011.</P>
          </EFFDATE>
          <FURINF>
            <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
            <P>Meredith Murphy, Defense Acquisition Regulations System, OUSD (AT&amp;L) DPAP (DARS), 3060 Defense Pentagon, Room 3B855, Washington, DC 20301-3060. Telephone 703-602-1302; facsimile 703-602-0350. Please cite DFARS Case 2011-D006.</P>
          </FURINF>
        </PREAMB>
        <SUPLINF>
          <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
          <P/>
          <HD SOURCE="HD1">I. Background</HD>
          <P>On September 27, 2010, DoD published a final rule under DFARS Case 2010-D015, DoD Office of the Inspector General (75 FR 59101). That final rule provided the address for the DoD Office of the Inspector General, as required by FAR clause 52.203-13, Contractor Code of Business Ethics and Conduct.</P>
          <P>This final rule corrects two omissions in that rule published in September 2010. At 203.1004(a), the clause prescription did not include the title of the clause at 252.203-7003. This rule adds the clause title to the prescription.</P>
          <P>The clause prescription at 203.1004 states that the clause at DFARS 252.203-7003 is used in solicitations and contracts that include the FAR clause at 52.203-13. FAR clause 52.203-13 is applicable to commercial items and is listed in FAR clause 52.212-5. If the contractor must make disclosures to the agency office of the Inspector General, as required by paragraph (b)(3)(i) of FAR 52.203-13, the contractor would need to know the address of the agency office of the Inspector General. However, DFARS case 2010-D015 did not add the DFARS clause at 252.203-7003, which provides the address of the DoD Office of the Inspector General, to the list of contract terms and conditions required to implement statutes or Executive orders applicable to Defense acquisitions of commercial items (DFARS 252.212-7001). This final rule remedies that omission. The rule also updates the list of clauses at 252.212-7001.</P>
          <HD SOURCE="HD1">II. Executive Orders 12866 and 13563</HD>
          <P>Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.</P>
          <HD SOURCE="HD1">III. Regulatory Flexibility Act</HD>
          <P>The Regulatory Flexibility Act does not apply to this rule because an initial regulatory flexibility analysis is only required for proposed or interim rules that require publication for public comment (5 U.S.C. 603) and a final regulatory flexibility analysis is only required for final rules that were previously published for public comment, and for which an initial regulatory flexibility analysis was prepared (5 U.S.C. 604).</P>
          <P>This final rule does not constitute a significant DFARS revision as defined at FAR 1.501-1 because this rule will not have a significant cost or administrative impact on contractors or offerors, or a significant effect beyond the internal operating procedures of the Government. Therefore, publication for public comment under 41 U.S.C. 1707 is not required.</P>
          <HD SOURCE="HD1">IV. Paperwork Reduction Act</HD>
          <P>The rule does not impose any new information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).</P>
          <LSTSUB>
            <HD SOURCE="HED">List of Subjects in 48 CFR Parts 203 and 252</HD>
            <P>Government procurement.</P>
          </LSTSUB>
          <SIG>
            <NAME>Ynette R. Shelkin,</NAME>
            <TITLE>Editor, Defense Acquisition Regulations System.</TITLE>
          </SIG>
          
          <P>Therefore, 48 CFR parts 203 and 252 are amended as follows:</P>
          <REGTEXT PART="203" TITLE="48">
            <AMDPAR>1. The authority citation for 48 CFR parts 203 and 252 continues to read as follows:</AMDPAR>
            <AUTH>
              <HD SOURCE="HED">Authority:</HD>
              <P>41 U.S.C. 1303 and 48 CFR chapter 1.</P>
            </AUTH>
          </REGTEXT>
          <REGTEXT PART="203" TITLE="48">
            <PART>
              <HD SOURCE="HED">PART 203—IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST</HD>
            </PART>
            <AMDPAR>2. Amend section 203.1004 by revising paragraph (a) to read as follows:</AMDPAR>
            <SECTION>
              <SECTNO>203.1004</SECTNO>
              <SUBJECT>Contract clauses.</SUBJECT>
              <P>(a) Use the clause at 252.203-7003, Agency Office of the Inspector General, in solicitations and contracts that include the FAR clause 52.203-13, Contractor Code of Business Ethics and Conduct.</P>
              <STARS/>
            </SECTION>
          </REGTEXT>
          <REGTEXT PART="252" TITLE="48">
            <PART>
              <HD SOURCE="HED">PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
            </PART>
            <AMDPAR>3. Amend section 252.212-7001 by revising the clause date and revising paragraph (b) to read as follows:</AMDPAR>
            <SECTION>
              <SECTNO>252.212-7001</SECTNO>
              <SUBJECT>Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items.</SUBJECT>
              <STARS/>
              <HD SOURCE="HD1">CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS APPLICABLE TO DEFENSE ACQUISITIONS OF COMMERCIAL ITEMS (JUN 2011)</HD>
              <EXTRACT>
                <STARS/>
                <P>(b) The Contractor agrees to comply with any clause that is checked on the following list of Defense FAR Supplement clauses which, if checked, is included in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items or components.</P>
                <P>(1) __ 252.203-7000, Requirements Relating to Compensation of Former DoD Officials (JAN 2009) (Section 847 of Pub. L. 110-181).</P>
                <P>(2) __252.203-7003, Agency Office of the Inspector General (SEP 2010) (Section 6101 of Pub. L. 110-252, 41 U.S.C. 3509 note).</P>

                <P>(3) __ 252.205-7000, Provision of Information to Cooperative Agreement Holders (DEC 1991) (10 U.S.C. 2416).<PRTPAGE P="32841"/>
                </P>
                <P>(4) __ 252.219-7003, Small Business Subcontracting Plan (DoD Contracts) (OCT 2010) (15 U.S.C. 637).</P>
                <P>(5) __ 252.219-7004, Small Business Subcontracting Plan (Test Program) (JAN 2011) (15 U.S.C. 637 note).</P>
                <P>(6)(i) __ 252.225-7001, Buy American Act and Balance of Payments Program (JAN 2009) (41 U.S.C. chapter 83, E.O. 10582).</P>
                <P>(ii) __ Alternate I (DEC 2010) of 252.225-7001.</P>
                <P>(7) __ 252.225-7008, Restriction on Acquisition of Specialty Metals (JUL 2009) (10 U.S.C. 2533b).</P>
                <P>(8) __ 252.225-7009, Restriction on Acquisition of Certain Articles Containing Specialty Metals (JAN 2011) (10 U.S.C. 2533b).</P>
                <P>(9) __ 252.225-7012, Preference for Certain Domestic Commodities (JUN 2010) (10 U.S.C. 2533a).</P>
                <P>(10) __ 252.225-7015, Restriction on Acquisition of Hand or Measuring Tools (JUN 2005) (10 U.S.C. 2533a).</P>
                <P>(11) __ 252.225-7016, Restriction on Acquisition of Ball and Roller Bearings (DEC 2010) (Section 8065 of Pub. L. 107-117 and the same restriction in subsequent DoD appropriations acts).</P>
                <P>(12)(i) __ 252.225-7021, Trade Agreements (NOV 2009) (19 U.S.C. 2501-2518 and 19 U.S.C. 3301 note).</P>
                <P>(ii) __ Alternate I (SEP 2008) of 252.225-7021.</P>
                <P>(iii) __ Alternate II (DEC 2010) of 252.225-7021.</P>
                <P>(13) __ 252.225-7027, Restriction on Contingent Fees for Foreign Military Sales (APR 2003) (22 U.S.C. 2779).</P>
                <P>(14) __ 252.225-7028, Exclusionary Policies and Practices of Foreign Governments (APR 2003) (22 U.S.C. 2755).</P>
                <P>(15)(i) __ 252.225-7036, Buy American Act—Free Trade Agreements—Balance of Payments Program (DEC 2010) (41 U.S.C. chapter 83, and 19 U.S.C. 3301 note).</P>
                <P>(ii) __ Alternate I (JUL 2009) of 252.225-7036.</P>
                <P>(iii) __ Alternate II (DEC 2010) of 252.225-7036.</P>
                <P>(iv) __ Alternate III (DEC 2010) of 252.225-7036.</P>
                <P>(16) __ 252.225-7038, Restriction on Acquisition of Air Circuit Breakers (JUN 2005) (10 U.S.C. 2534(a)(3)).</P>
                <P>(17) __ 252.226-7001, Utilization of Indian Organizations, Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns (SEP 2004) (Section 8021 of Pub. L. 107-248 and similar sections in subsequent DoD appropriations acts).</P>
                <P>(18) __ 252.227-7015, Technical Data—Commercial Items (MAR 2011) (10 U.S.C. 2320).</P>
                <P>(19) __ 252.227-7037, Validation of Restrictive Markings on Technical Data (SEP 1999) (10 U.S.C. 2321).</P>
                <P>(20) __ 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports (MAR 2008) (10 U.S.C. 2227).</P>
                <P>(21) __ 252.237-7010, Prohibition on Interrogation of Detainees by Contractor Personnel (NOV 2010) (Section 1038 of Pub. L. 111-84).</P>
                <P>(22) __ 252.237-7019, Training for Contractor Personnel Interacting with Detainees (SEP 2006) (Section 1092 of Pub. L. 108-375).</P>
                <P>(23) __ 252.243-7002, Requests for Equitable Adjustment (MAR 1998) (10 U.S.C. 2410).</P>
                <P>(24) __ 252.246-7004, Safety of Facilities, Infrastructure, and Equipment For Military Operations (OCT 2010) (Section 807 of Pub. L. 111-84).</P>
                <P>(25)__ 252.247-7003, Pass-Through of Motor Carrier Fuel Surcharge Adjustment to the Cost Bearer (SEP 2010) (Section 884 of Pub. L. 110-417).</P>
                <P>(26)(i) __ 252.247-7023, Transportation of Supplies by Sea (MAY 2002) (10 U.S.C. 2631).</P>
                <P>(ii) __ Alternate I (MAR 2000) of 252.247-7023.</P>
                <P>(iii) __ Alternate II (MAR 2000) of 252.247-7023.</P>
                <P>(iv) __ Alternate III (MAY 2002) of 252.247-7023.</P>
                <P>(27) __ 252.247-7024, Notification of Transportation of Supplies by Sea (MAR (2000) (10 U.S.C. 2631).</P>
              </EXTRACT>
            </SECTION>
          </REGTEXT>
          
        </SUPLINF>
        <FRDOC>[FR Doc. 2011-13648 Filed 6-3-11; 8:45 am]</FRDOC>
        <BILCOD>BILLING CODE 5001-08-P</BILCOD>
      </RULE>
      <RULE>
        <PREAMB>
          <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
          <SUBAGY>Defense Acquisition Regulations System</SUBAGY>
          <CFR>48 CFR Parts 225 and 252</CFR>
          <RIN>RIN 0750-AH16</RIN>
          <SUBJECT>Defense Federal Acquisition Regulation Supplement; Foreign Acquisition Amendments (DFARS Case 2011-D017)</SUBJECT>
          <AGY>
            <HD SOURCE="HED">AGENCY:</HD>
            <P>Defense Acquisition Regulations System, Department of Defense (DoD).</P>
          </AGY>
          <ACT>
            <HD SOURCE="HED">ACTION:</HD>
            <P>Final rule.</P>
          </ACT>
          <SUM>
            <HD SOURCE="HED">SUMMARY:</HD>
            <P>DoD is amending the Defense Federal Acquisition Regulation Supplement (DFARS) to correct several anomalies resulting from recent changes relating to source of ball and roller bearing components, eligibility of Peruvian end products under trade agreements, and participation of foreign contractors in acquisitions in support of operations in Afghanistan.</P>
          </SUM>
          <DATES>
            <HD SOURCE="HED">DATES:</HD>
            <P>
              <E T="03">Effective Date:</E>June 6, 2011.</P>
          </DATES>
          <FURINF>
            <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
            <P>Ms. Amy G. Williams, Defense Acquisition Regulations System, OUSD (AT&amp;L) DPAP/DARS, Room 3B855, 3060 Defense Pentagon, Washington, DC 20301-3060. Telephone 703-602-0328; facsimile 703-602-0350.</P>
          </FURINF>
        </PREAMB>
        <SUPLINF>
          <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
          <HD SOURCE="HD1">I. Background</HD>
          <P>DoD is amending the DFARS to correct several anomalies resulting from recent changes relating to source of ball and roller bearing components, participation of foreign contractors in acquisitions in support of operations in Afghanistan, and eligibility of Peruvian end products under trade agreements.</P>
          <HD SOURCE="HD2">A. Restriction on Ball and Roller Bearings</HD>

          <P>DoD published a proposed rule, Restrictions on Ball and Roller Bearings (DFARS Case 2006-D029), in the<E T="04">Federal Register</E>(75 FR 25167) on May 7, 2010 with request for comments. DoD received comments from three respondents and addressed the comments in the publication of the final rule (75 FR 76297) on December 8, 2010. DFARS Case 2006-D029 retained the existing definition of “bearing component”. As used in DFARS part 225 and the DFARS clause 252.225-7016, “bearing component” means the bearing element, retainer, inner race, or outer race (see 252.225-7016(a)). However, that rule added a new requirement at 225.7009-2(a)(2) and 252.225-7016(b)(2) that for each ball or roller bearing, the cost of the bearing components “mined, produced, or manufactured” in the United States or Canada must exceed 50 percent of the total cost of the bearing components of that ball or roller bearing.</P>

          <P>The phrase “mined, produced, or manufactured” was adopted from the Buy American Act, which applies broadly to many types of items. This rule applies only to bearing components, which are manufactured items and not mined or produced. As used in the DFARS, the term “bearing component” does not refer to the materials that are utilized in the manufacture of the bearing components. There is no restriction with regard to where the iron ore is mined or where the resultant steel in a bearing component is produced. The requirement at 225.7009-2(a)(2) and 252.225-7016(b)(2) that for each ball or roller bearing, the cost of the bearing components “mined, produced, or manufactured” in the United States or Canada must exceed 50 percent of the total cost of the bearing components of that ball or roller bearing, has the same meaning as a requirement that for each ball or roller bearing, the cost of the bearing components “manufactured” in the United States or Canada must exceed 50 percent of the total cost of the bearing components of that ball or roller bearing. The words “mined” and “produced” are extraneous because they are inapplicable, since a ball or roller bearing is manufactured and not mined or produced. Therefore, this final rule under DFARS Case 2011-D017 removes the words “mined, produced, or” and<PRTPAGE P="32842"/>retains only the term “manufactured”, to clarify the definition and alleviate any confusion these extraneous words may cause industry or Government personnel.</P>
          <P>This final rule also makes a conforming change to the clause date for 252.225-7016, Restriction on the Acquisition of Ball and Roller Bearings, in the clause at 252.212-7001, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items.</P>
          <HD SOURCE="HD2">B. Foreign Participation in Acquisitions in Support of Operations in Afghanistan</HD>

          <P>DoD published a proposed rule, “Foreign Participation in Acquisitions in Support of Operations in Afghanistan” on January 6, 2010 (DFARS Case 2009-D012)(75 FR 832), with request for public comments. DoD did not receive any public comments on the proposed rule. DoD published the final rule in the<E T="04">Federal Register</E>(75 FR 81915) on December 29, 2010.</P>
          <P>Although no public comments were received, DoD realized that the requirement for a contractor to inform its government of its participation in the acquisition should only apply if the contractor is from a South Caucasus/Central and South Asian (SC/CASA) state. The United States Trade Representative, when providing authority to the Secretary of Defense to waive the procurement prohibition in section 302(a) of the Trade Agreements Act of 1979 (USTR letter of June 2, 2009), included the provision that contractors from the SC/CASA states, which would not have been eligible to participate in the acquisition absent the waiver, advise their governments that they will generally not have such opportunities in the future unless their governments provide reciprocal procurement opportunities to U.S. products and services.</P>
          <P>This requirement has meaning only when applied to a contractor from an SC/CASA state, to which the waiver applies. The required statement that the contractor would not have been eligible to participate in the acquisition absent the waiver would not be true for a contractor from other than an SC/CASA state. It would also be meaningless to ask a U.S. contractor to notify its government (the U.S. Government) that it should provide reciprocal procurement opportunities to U.S. products and services. However, the proposed rule did not explicitly limit the application of this requirement to contractors from an SC/CASA state.</P>
          <P>The final rule under DFARS Case 2009-D012 revised paragraph (d) of Alternate II of DFARS clause 252.225-7021, Trade Agreements, to limit applicability to contractors from an SC/CASA state. The final rule inadvertently omitted similar amendment of the same requirement in paragraphs (d) of Alternates II and III of DFARS clause 252.225-7045, Balance of Payments Program—Construction Material Under Trade Agreements.</P>
          <P>This final rule under DFARS Case 2011-D017 remedies that oversight, adding “If the Contractor is from an SC/CASA state” to paragraph (d) in Alternates II and III of DFARS clause 252.225-7045, Buy American Act—Free Trade Agreements—Balance of Payments Program Certificate, to conform to the same revision made under DFARS Case 2009-D012 to paragraph (d) of Alternate I of DFARS clause 252.225-7021.</P>
          <HD SOURCE="HD2">C. Trade Agreements—Peru</HD>
          <P>The Peruvian Free Trade Agreement was initially implemented by DFARS Case 2008-D046, Trade Agreement—Costa Rica and Peru, that was published as an interim rule with a request for public comment (74 FR 37650). No public comments were received and the interim rule was converted to a final rule without change on July 29, 2009 (75 FR 179). This final rule added Peru to the definition of “Free Trade Agreement country” in DFARS clauses 252.225-7021, 252.225-7036, and 252.225-7045.</P>
          <P>In order to make some further implementation of the Peru Free Trade Agreement in the trade agreements clauses, DoD utilized the final rule issued under DFARS Case 2009-D012, although the issue of the Peru Free Trade Agreement was peripheral to the main purpose of that case. DoD added a definition of Peruvian end products and added Peruvian end products to the Free Trade Agreement country end products that are not eligible products in the provision and clause at DFARS 252.225-7035 and 252.225-7036. This is consistent with the Peru Free Trade Agreement and the FAR, and ensures that Peruvian end products are not erroneously treated as eligible products in acquisitions that do not exceed the World Trade Organization Government Procurement Agreement threshold.</P>
          <P>This change, however, created an inconsistency between Alternate I and the basic clause 252.225-7035. The basic clause now includes in paragraph (b)(2) the phrase “Free Trade Agreement country end products other than Bahrainian end products or Moroccan end products, or Peruvian end products.” The Alternate I, which limits the applicable Free Trade Agreements to just Canada, misquotes the phrase that is to be removed and replaced with the phrase “Canadian end products.” Alternate I still quotes the old unrevised phrase as “Free Trade Agreement country end products other than Bahrainian end products or Moroccan end products” and leaves off “or Peruvian end products” that was added by 2009-D012 final rule. Even though this phrase is being removed by Alternate I, the misquote creates an inconsistency, which might cause some confusion, although all of the corresponding regulations make it clear that the Peruvian Trade Agreement does not apply below the threshold of $70,079, when Alternate I is used (see threshold at FAR 25.402(b), clause prescription at DFARS 225.1101(10)(i), and comparable FAR clause 52.225-3 Alternate I).</P>
          <P>These DFARS changes are characterized as clarifications and corrections to DFARS language that do not constitute significant revisions, as defined in FAR 1.501-1, because they do not alter the substantive meaning of the coverage.</P>
          <HD SOURCE="HD1">II. Executive Orders 12866 and 13563</HD>
          <P>Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.</P>
          <HD SOURCE="HD1">III. Regulatory Flexibility Act</HD>
          <P>The Regulatory Flexibility Act does not apply to this rule because an initial regulatory flexibility analysis is only required for proposed or interim rules that require publication for public comment (5 U.S.C. 603) and a final regulatory flexibility analysis is only required for final rules that were previously published for public comment, and for which an initial regulatory flexibility analysis was prepared (5 U.S.C. 604).</P>

          <P>This final rule does not constitute a significant DFARS revision as defined at FAR 1.501-1 because this rule will not have a significant cost or administrative impact on contractors or offerors, or a<PRTPAGE P="32843"/>significant effect beyond the internal operating procedures of the Government. Therefore, publication for public comment under 41 U.S.C. 1707 is not required.</P>
          <HD SOURCE="HD1">IV. Paperwork Reduction Act</HD>
          <P>The final rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).</P>
          <LSTSUB>
            <HD SOURCE="HED">List of Subjects in 48 CFR Parts 225 and 252</HD>
            <P>Government procurement.</P>
          </LSTSUB>
          <SIG>
            <NAME>Ynette R. Shelkin,</NAME>
            <TITLE>Editor, Defense Acquisition Regulations System.</TITLE>
          </SIG>
          
          <P>Therefore, 48 CFR parts 225 and 252 are amended as follows:</P>
          <REGTEXT PART="225" TITLE="48">
            <AMDPAR>1. The authority citation for 48 CFR parts 225 and 252 continues to read as follows:</AMDPAR>
            <AUTH>
              <HD SOURCE="HED">Authority:</HD>
              <P>41 U.S.C. 1303 and 48 CFR chapter 1.</P>
            </AUTH>
            <PART>
              <HD SOURCE="HED">PART 225—FOREIGN ACQUISITION</HD>
              <SECTION>
                <SECTNO>225.7009-2</SECTNO>
                <SUBJECT>[Amended]</SUBJECT>
              </SECTION>
            </PART>
            <AMDPAR>2. Amend section 225.7009-2 by removing from paragraph (a)(2) the words “mined, produced, or”.</AMDPAR>
          </REGTEXT>
          <REGTEXT PART="252" TITLE="48">
            <PART>
              <HD SOURCE="HED">PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
              <SECTION>
                <SECTNO>252.212-7001</SECTNO>
                <SUBJECT>[Amended]</SUBJECT>
              </SECTION>
            </PART>
            <AMDPAR>3. Amend section 252.212-7001 by revising the clause date in paragraph (b)(11) by removing “(DEC 2010)” and adding in its place “(JUN 2011)”.</AMDPAR>
          </REGTEXT>
          <REGTEXT PART="252" TITLE="48">
            <SECTION>
              <SECTNO>252.225-7016</SECTNO>
              <SUBJECT>[Amended]</SUBJECT>
            </SECTION>
            <AMDPAR>4. Amend section 252.225-7016 as follows:</AMDPAR>
            <AMDPAR>a. Revise the clause date by removing “(DEC 2010)” and adding in its place “(JUN 2011)”.</AMDPAR>
            <AMDPAR>b. Amend paragraph (b)(2) by removing the words “mined, produced, or”.</AMDPAR>
          </REGTEXT>
          <REGTEXT PART="252" TITLE="48">
            <AMDPAR>5. Amend section 252.225-7035 by revising Alternate I to read as follows:</AMDPAR>
            <SECTION>
              <SECTNO>252.225-7035</SECTNO>
              <SUBJECT>Buy American Act—Free Trade Agreements—Balance of Payments Program Certificate</SUBJECT>
              <HD SOURCE="HD1">ALTERNATE I (JUN 2011)</HD>
              <EXTRACT>
                <P>As prescribed in 225.1101(10)(ii), substitute the phrase “Canadian end product” for the phrases “Bahrainian end product,” “Free Trade Agreement country,” “Free Trade Agreement country end product,” “Moroccan end product,” and “Peruvian end product” in paragraph (a) of the basic provision; substitute the phrase “Canadian end products” for the phrase “Free Trade Agreement country end products other than Bahrainian end products, Moroccan end products, or Peruvian end products” in paragraphs (b)(2) and (c)(2)(ii) of the basic provision; and delete the phrase “Australian or” from paragraph (c)(2)(i) of the basic provision.</P>
              </EXTRACT>
            </SECTION>
          </REGTEXT>
          <REGTEXT PART="252" TITLE="48">
            <SECTION>
              <SECTNO>252.225-7045</SECTNO>
              <SUBJECT>[Amended]</SUBJECT>
            </SECTION>
            <AMDPAR>6. Amend section 252.225-7045 as follows:</AMDPAR>
            <AMDPAR>a. Revise the clause date of Alternate II by removing “(DEC 2010)” and adding in its place “(JUN 2011)”.</AMDPAR>
            <AMDPAR>b. Amend paragraph (d) of Alternate II by removing “The” and adding in its place “If the Contractor is from an SC/CASA state, the”.</AMDPAR>
            <AMDPAR>c. Revise the clause date of Alternate III by removing “(DEC 2010)” and adding in its place “(JUN 2011)”.</AMDPAR>
            <AMDPAR>d. Amend paragraph (d) of Alternate III by removing “The” and adding in its place “If the Contractor is from an SC/CASA state, the”.</AMDPAR>
          </REGTEXT>
          
        </SUPLINF>
        <FRDOC>[FR Doc. 2011-13797 Filed 6-3-11; 8:45 am]</FRDOC>
        <BILCOD>BILLING CODE 5001-08-P</BILCOD>
      </RULE>
      <RULE>
        <PREAMB>
          <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
          <SUBAGY>Defense Acquisition Regulations System</SUBAGY>
          <CFR>48 CFR Part 225</CFR>
          <RIN>RIN 0750-AH22</RIN>
          <SUBJECT>Defense Federal Acquisition Regulation Supplement; Fire-Resistant Fiber for Production of Military Uniforms (DFARS Case 2011-D021)</SUBJECT>
          <AGY>
            <HD SOURCE="HED">AGENCY:</HD>
            <P>Defense Acquisition Regulations System, Department of Defense (DoD).</P>
          </AGY>
          <ACT>
            <HD SOURCE="HED">ACTION:</HD>
            <P>Interim rule with request for comments.</P>
          </ACT>
          <SUM>
            <HD SOURCE="HED">SUMMARY:</HD>
            <P>DoD is issuing an interim rule to implement section 821 of the National Defense Authorization Act for Fiscal Year 2011. Section 821 prohibits specification of the use of fire-resistant rayon fiber in solicitations issued before January 1, 2015.</P>
          </SUM>
          <EFFDATE>
            <HD SOURCE="HED">DATES:</HD>
            <P>
              <E T="03">Effective date:</E>June 6, 2011.</P>
            <P>
              <E T="03">Comment date:</E>Comments on the interim rule should be submitted in writing to the address shown below on or before August 5, 2011.</P>
          </EFFDATE>
          <ADD>
            <HD SOURCE="HED">ADDRESSES:</HD>
            <P>Submit comments identified by DFARS Case 2011-D021, using any of the following methods:</P>
            <P>○<E T="03">Regulations.gov:</E>
              <E T="03">http://www.regulations.gov</E>.</P>
            <P>Submit comments via the Federal eRulemaking portal by inputting “DFARS Case 2011-D021” under the heading “Enter keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “DFARS Case 2011-D021.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “DFARS Case 2011-D021” on your attached document.</P>
            <P>○<E T="03">E-mail:</E>
              <E T="03">dfars@osd.mil.</E>Include DFARS Case 2011-D021 in the subject line of the message.</P>
            <P>○<E T="03">Fax:</E>703-602-0350.</P>
            <P>○<E T="03">Mail:</E>Defense Acquisition Regulations System, Attn: Amy G. Williams, OUSD (AT&amp;L) DPAP/DARS, Room 3B855, 3060 Defense Pentagon, Washington, DC 20301-3060.</P>

            <P>Comments received generally will be posted without change to<E T="03">http://www.regulations.gov</E>, including any personal information provided. To confirm receipt of your comment(s), please check<E T="03">http://www.regulations.gov</E>approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).</P>
          </ADD>
        </PREAMB>
        <SUPLINF>
          <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
          <HD SOURCE="HD1">I. Background</HD>
          <P>This interim rule amends DFARS subpart 225.70 to implement section 821 of the National Defense Authorization Act for Fiscal Year 2011 (Pub. L. 111-383). Section 821 prohibits specification of the use of fire-resistant rayon fiber in solicitations issued before January 1, 2015.</P>
          <HD SOURCE="HD1">II. Executive Orders 12866 and 13563</HD>
          <P>Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.</P>
          <HD SOURCE="HD1">III. Regulatory Flexibility Act</HD>

          <P>DoD does not expect this interim rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,<E T="03">et seq.</E>
            <PRTPAGE P="32844"/>However, an initial regulatory flexibility analysis has been prepared and is summarized as follows:</P>
          <P>The objectives of this interim rule are to prohibit specification of the use of fire-resistant rayon fiber in solicitations issued before January 1, 2015, as required by the statute. This will provide opportunity for offerors to propose alternative solutions to meet DoD requirements.</P>
          <P>The legal basis for this interim rule is section 821 of the National Defense Authorization Act for Fiscal Year 2011 (Pub. L. 111-383).</P>
          <P>The two major sources of fire-resistant fiber used in DoD products either come from DuPont (product called Nomex) or The Lenzing Group, Austria (product called Fire-Resistant Rayon). In order to manufacture a fire-resistant uniform currently being sourced by the services, three products are blended together to meet desired cost, availability, and performance criteria:</P>
          <P>• Nylon;</P>
          <P>• Para-aramid (Kevlar by DuPont or Twaron by Teijin (the Netherlands)); and</P>
          <P>• Either Nomex (DuPont) or Fire-Resistant Rayon (Lenzing).</P>
          <P>DuPont is a domestic large business and the other players are foreign. Therefore, this rule will have minimal impact on U.S. small businesses.</P>
          <P>This rule does not impose any reporting or recordkeeping requirements.</P>
          <P>The rule does not duplicate, overlap, or conflict with any other Federal rules.</P>
          <P>There are no significant alternatives to accomplish the stated objectives of this rule. The rule specifically implements the statutory requirement.</P>
          <P>DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.</P>
          <P>DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2011-D021) in correspondence.</P>
          <HD SOURCE="HD1">V. Paperwork Reduction Act</HD>
          <P>The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).</P>
          <HD SOURCE="HD1">VI. Determination To Issue an Interim Rule</HD>
          <P>A determination has been made under the authority of the Secretary of Defense, that urgent and compelling reasons exist to publish an interim rule prior to affording the public an opportunity to comment. This interim rule implements section 821 of the National Defense Authorization Act for Fiscal Year 2011. This requirement became effective upon enactment on January 7, 2011. This action is necessary in order to enable contracting officers to comply with this new requirement. Comments received in response to this interim rule will be considered in the formation of the final rule.</P>
          <LSTSUB>
            <HD SOURCE="HED">List of Subjects in 48 CFR Part 225</HD>
            <P>Government procurement.</P>
          </LSTSUB>
          <SIG>
            <NAME>Ynette R. Shelkin,</NAME>
            <TITLE>Editor, Defense Acquisition Regulations System.</TITLE>
          </SIG>
          
          <P>Therefore, 48 CFR part 225 is amended as follows:</P>
          <REGTEXT PART="225" TITLE="48">
            <PART>
              <HD SOURCE="HED">PART 225—FOREIGN ACQUISITION</HD>
            </PART>
            <AMDPAR>1. The authority citation for 48 CFR part 225 continues to read as follows:</AMDPAR>
            
          </REGTEXT>
          <REGTEXT PART="225" TITLE="48">
            <AUTH>
              <HD SOURCE="HED">Authority:</HD>
              <P>41 U.S.C. 1303 and 48 CFR chapter 1.</P>
            </AUTH>
            <AMDPAR>2. In subpart 225.70, add section 225.7016 to read as follows:</AMDPAR>
            <SECTION>
              <SECTNO>225.7016</SECTNO>
              <SUBJECT>Prohibition.</SUBJECT>
              <P>In accordance with section 821 of the National Defense Authorization Act for Fiscal Year 2011, do not include in any solicitation issued before January 1, 2015, a requirement that proposals submitted pursuant to such solicitation shall include the use of fire-resistant rayon fiber.</P>
            </SECTION>
          </REGTEXT>
          
        </SUPLINF>
        <FRDOC>[FR Doc. 2011-13368 Filed 6-3-11; 8:45 am]</FRDOC>
        <BILCOD>BILLING CODE 5001-08-P</BILCOD>
      </RULE>
    </RULES>
  </NEWPART>
  <VOL>76</VOL>
  <NO>108</NO>
  <DATE>Monday, June 6, 2011</DATE>
  <UNITNAME>Proposed Rules</UNITNAME>
  <NEWPART>
    <PRORULES>
      <PRORULE>
        <PREAMB>
          <PRTPAGE P="32845"/>
          <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
          <SUBAGY>Defense Acquisition Regulations System</SUBAGY>
          <CFR>48 CFR Part 252</CFR>
          <RIN>RIN 0750-AH21</RIN>
          <SUBJECT>Defense Federal Acquisition Regulation Supplement; Definition of “Qualifying Country End Product” (DFARS Case 2011-D028)</SUBJECT>
          <AGY>
            <HD SOURCE="HED">AGENCY:</HD>
            <P>Defense Acquisition Regulations System, Department of Defense (DoD).</P>
          </AGY>
          <ACT>
            <HD SOURCE="HED">ACTION:</HD>
            <P>Proposed rule.</P>
          </ACT>
          <SUM>
            <HD SOURCE="HED">SUMMARY:</HD>
            <P>DoD is issuing a proposed rule to amend the definition of “qualifying country end product” by eliminating the component test for qualifying country end products that are commercially available off-the-shelf items.</P>
          </SUM>
          <DATES>
            <HD SOURCE="HED">DATES:</HD>
            <P>Comments on the proposed rule should be submitted in writing to the address shown below on or before August 5, 2011, to be considered in the formation of the final rule.</P>
          </DATES>
          <ADD>
            <HD SOURCE="HED">ADDRESSES:</HD>
            <P>Submit comments identified by DFARS Case 2011-D028, using any of the following methods:</P>
            <P>○<E T="03">Regulations.gov: http://www.regulations.gov.</E>
            </P>
            <P>Submit comments via the Federal eRulemaking portal by inputting “DFARS Case 2011-D028” under the heading “Enter keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “DFARS Case 2011-D028.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “DFARS Case 2011-D028” on your attached document.</P>
            <P>○<E T="03">E-mail: dfars@osd.mil.</E>Include DFARS Case 2011-D028 in the subject line of the message.</P>
            <P>○<E T="03">Fax:</E>703-602-0350.</P>
            <P>○<E T="03">Mail:</E>Defense Acquisition Regulations System, Attn: Amy G. Williams, OUSD (AT&amp;L) DPAP/DARS, Room 3B855, 3060 Defense Pentagon, Washington, DC 20301-3060.</P>

            <P>Comments received generally will be posted without change to<E T="03">http://www.regulations.gov,</E>including any personal information provided. To confirm receipt of your comment(s), please check<E T="03">http://www.regulations.gov</E>approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).</P>
          </ADD>
        </PREAMB>
        <SUPLINF>
          <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
          <HD SOURCE="HD1">I. Background</HD>
          <P>This rule proposes to amend the definition of “qualifying country end product” to remove the component test for qualifying country end products that are commercially available off-the-shelf items.</P>
          <P>Under the Buy American Act, there is a two-part test to define a domestic end product. The product must be manufactured in the United States and there is a formula based on the cost of foreign components compared to the cost of all components. Under FAR Case 2000-305, the component test was waived for the acquisition of commercially available off-the-shelf (COTS) items (see FAR 25.001(c)(1)). Likewise, the component test for the DFARS definition of “domestic end product” was waived by the interim rule of DFARS Case 2008-D009 (74 FR 2422, January 15, 2009) and final rule published December 24, 2009 (74 FR 68384). These changes were based on a determination signed by the Administrator for Federal Procurement Policy on February 14, 2008, regarding laws applicable to the acquisition of COTS items. According to the determination, the component test of the Buy American Act (41 U.S.C. chapter 83) does not apply to COTS items.</P>
          <P>The definition of “qualifying country end product” is not statutory, but it was modeled after the definition of “domestic end product” as a matter of policy. Therefore, it is within the authority of DoD to change this definition as a matter of policy, to waive the component test for qualifying country end products that are COTS items, so that it will not be necessary to try to track the origin of components of COTS items that are manufactured in a qualifying country, in order to determine that an end product is a qualifying country end product.</P>
          <HD SOURCE="HD1">II. Executive Orders 12866 and 13563</HD>
          <P>Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and, therefore, was subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.</P>
          <HD SOURCE="HD1">III. Regulatory Flexibility Act</HD>

          <P>DoD does not expect this rule to have a significant impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,<E T="03">et seq.,</E>because the rule only affects manufacturers of COTS items in qualifying countries, removing an administrative burden for the qualifying country manufacturer and the Government personnel acquiring the items. The Regulatory Flexibility Act is intended to protect small entities in the United States, not foreign entities, regardless of size. For the definition of “small business”, the Regulatory Flexibility Act refers to the Small Business Act, which in turn allows the SBA Administrator to specify detailed definitions or standards. 5 U.S.C. 601(3) and 15 U.S.C. 632(a). The SBA regulations at 13 CFR 121.105 discuss who is a small business: ” (a)(1) Except for small agricultural cooperatives, a business concern eligible for assistance from SBA as a small business is a business entity organized for profit, with a place of business located in the United States, and which operates primarily within the United States or which makes a significant contribution to the U.S. economy through payment of taxes or use of American products, materials or labor.” The comparable change has already been enacted for the benefit of U.S. manufacturers of COTS items in the DFARS which aligns with the FAR. Therefore, an initial regulatory flexibility analysis has not been performed. DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.</P>
          <P>DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2011-D029) in correspondence.</P>
          <HD SOURCE="HD1">V. Paperwork Reduction Act</HD>
          <P>The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).</P>
          <LSTSUB>
            <PRTPAGE P="32846"/>
            <HD SOURCE="HED">List of Subjects in 48 CFR Part 252</HD>
            <P>Government procurement.</P>
          </LSTSUB>
          <SIG>
            <NAME>Ynette R. Shelkin,</NAME>
            <TITLE>Editor, Defense Acquisition Regulations System.</TITLE>
          </SIG>
          
          <P>Therefore, 48 CFR part 252 is proposed to be amended as follows:</P>
          <PART>
            <HD SOURCE="HED">PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
            <P>1. The authority citation for 48 CFR part 252 continues to read as follows:</P>
            <AUTH>
              <HD SOURCE="HED">Authority:</HD>
              <P>41 U.S.C. 1303 and 48 CFR chapter 1.</P>
            </AUTH>
            
            <P>2. Amend section 252.212-7001 by revising the clause date, and paragraphs (b)(5)(i), (b)(11)(i), (b)(14)(i), (b)(20), and (b)(21) to read as as follows:</P>
            <SECTION>
              <SECTNO>252.212-7001</SECTNO>
              <SUBJECT>Contract terms and conditions required to implement statutes or executive orders applicable to defense acquisitions of commercial items.</SUBJECT>
              <STARS/>
              <HD SOURCE="HD1">CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS APPLICABLE TO DEFENSE ACQUISITIONS OF COMMERCIAL ITEMS (DATE)</HD>
              <EXTRACT>
                <STARS/>
                <P>(b) * * *</P>
                <P>(5)(i)____252.225-7001, Buy American Act and Balance of Payments Program (DATE) (41 U.S.C. chapter 83, E.O. 10582).</P>
                <STARS/>
                <P>(11)(i)____252.225-7021, Trade Agreements (DATE) (19 U.S.C. 2501-2518 and 19 U.S.C. 3301 note)</P>
                <STARS/>
                <P>(14)(i)____ 252.225-7036, Buy American Act—Free Trade Agreements—Balance of Payments Program (DATE) (41 U.S.C. chapter 83 and 19 U.S.C. 3301 note)</P>
                <STARS/>
                <P>(20)____252.237-7010, Prohibition on Interrogation of Detainees by Contractor Personnel (NOV 2010) (Section 1038 of Pub. L. 111-84).</P>
                <P>(21)____252.237-7019, Training for Contractor Personnel Interacting with Detainees (SEP 2006) (Section 1092 of Public Law 108-375).</P>
                <STARS/>
              </EXTRACT>
              <P>3. Amend section 252.225-7001 by revising the clause date, paragraph (a)(8), and paragraph (b) to read as follows:</P>
            </SECTION>
            <SECTION>
              <SECTNO>252.225-7001</SECTNO>
              <SUBJECT>Buy American Act and Balance of Payments Program.</SUBJECT>
              <STARS/>
              <HD SOURCE="HD1">BUY AMERICAN ACT AND BALANCE OF PAYMENTS PROGRAM (DATE)</HD>
              <EXTRACT>
                <P>(a) * * *</P>
                <P>(8)<E T="03">Qualifying country end product</E>means—</P>
                <P>(i) An unmanufactured end product mined or produced in a qualifying country; or</P>
                <P>(ii) An end product manufactured in a qualifying country if—</P>
                <P>(A) The cost of the following types of components exceeds 50 percent of the cost of all its components:</P>
                <P>(<E T="03">1</E>) Components mined, produced, or manufactured in a qualifying country.</P>
                <P>(<E T="03">2</E>) Components mined, produced, or manufactured in the United States.</P>
                <P>(<E T="03">3</E>) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States; or</P>
                <P>(B) The end product is a COTS item.</P>
                <STARS/>
                <P>(b) This clause implements the Buy American Act (41 U.S.C. chapter 83). In accordance with 41 U.S.C. 1907, the component test of the Buy American Act is waived for an end product that is a COTS item (see section 12.505(a)(1) of the Federal Acquisition Regulation). Unless otherwise specified, this clause applies to all line items in the contract.</P>
                <STARS/>
              </EXTRACT>
              <P>4. Amend section 252.225-7021 by revising the clause date and paragraph (a)(10) to read as follows:</P>
            </SECTION>
            <SECTION>
              <SECTNO>252.225-7021</SECTNO>
              <SUBJECT>Trade agreements.</SUBJECT>
              <STARS/>
              <HD SOURCE="HD1">TRADE AGREEMENTS (DATE)</HD>
              <EXTRACT>
                <P>(a) * * *</P>
                <P>(10)<E T="03">Qualifying country end product</E>means—</P>
                <P>(i) An unmanufactured end product mined or produced in a qualifying country; or</P>
                <P>(ii) An end product manufactured in a qualifying country if—</P>
                <P>(A) The cost of the following types of components exceeds 50 percent of the cost of all its components:</P>
                <P>(<E T="03">1</E>) Components mined, produced, or manufactured in a qualifying country.</P>
                <P>(<E T="03">2</E>) Components mined, produced, or manufactured in the United States.</P>
                <P>(<E T="03">3</E>) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States; or</P>
                <P>(B) The end product is a COTS item.</P>
                <STARS/>
              </EXTRACT>
              <P>5. Amend section 252.225-7036 by revising the clause date and paragraph (a)(13) to read as follows:</P>
            </SECTION>
            <SECTION>
              <SECTNO>252.225-7036</SECTNO>
              <SUBJECT>Buy American Act—Free Trade Agreements—Balance of Payments Program.</SUBJECT>
              <STARS/>
              <HD SOURCE="HD1">BUY AMERICAN ACT—FREE TRADE AGREEMENTS—BALANCE OF PAYMENTS PROGRAM (DATE)</HD>
              <EXTRACT>
                <P>(a) * * *</P>
                <P>(13)<E T="03">Qualifying country end product</E>means—</P>
                <P>(i) An unmanufactured end product mined or produced in a qualifying country; or</P>
                <P>(ii) An end product manufactured in a qualifying country if—</P>
                <P>(A) The cost of the following types of components exceeds 50 percent of the cost of all its components:</P>
                <P>(<E T="03">1</E>) Components mined, produced, or manufactured in a qualifying country.</P>
                <P>(<E T="03">2</E>) Components mined, produced, or manufactured in the United States.</P>
                <P>(<E T="03">3</E>) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States; or</P>
                <P>(B) The end product is a COTS item.</P>
                <STARS/>
              </EXTRACT>
            </SECTION>
          </PART>
        </SUPLINF>
        <FRDOC>[FR Doc. 2011-13367 Filed 6-3-11; 8:45 am]</FRDOC>
        <BILCOD>BILLING CODE 5001-08-P</BILCOD>
      </PRORULE>
      <PRORULE>
        <PREAMB>
          <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
          <SUBAGY>Defense Acquisition Regulations System</SUBAGY>
          <CFR>48 CFR Parts 203, 204, and 252</CFR>
          <RIN>RIN 0750-AG99</RIN>
          <SUBJECT>Defense Federal Acquisition Regulation Supplement; Representation Relating to Compensation of Former DoD Officials (DFARS Case 2010-D020)</SUBJECT>
          <AGY>
            <HD SOURCE="HED">AGENCY:</HD>
            <P>Defense Acquisition Regulations System; Department of Defense (DoD).</P>
          </AGY>
          <ACT>
            <HD SOURCE="HED">ACTION:</HD>
            <P>Proposed rule.</P>
          </ACT>
          <SUM>
            <HD SOURCE="HED">SUMMARY:</HD>
            <P>DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to require that offerors represent whether former DoD officials employed by the offeror are in compliance with post-employment restrictions.</P>
          </SUM>
          <EFFDATE>
            <HD SOURCE="HED">DATES:</HD>
            <P>Comments on the proposed rule should be submitted in writing to the address shown below on or before August 5, 2011, to be considered in the formation of the final rule.</P>
          </EFFDATE>
          <ADD>
            <HD SOURCE="HED">ADDRESSES:</HD>
            <P>Submit comments identified by DFARS Case 2010-D020, using any of the following methods:</P>
            <P>○<E T="03">Regulations.gov: http://www.regulations.gov.</E>
            </P>

            <P>Submit comments via the Federal eRulemaking portal by inputting “DFARS Case 2010-D020” under the heading “Enter keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “DFARS Case 2010-D020.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and<PRTPAGE P="32847"/>“DFARS Case 2010-D020” on your attached document.</P>
            <P>○<E T="03">E-mail: dfars@osd.mil.</E>Include DFARS Case 2010-D020 in the subject line of the message.</P>
            <P>○<E T="03">Fax:</E>703-602-0350.</P>
            <P>○<E T="03">Mail:</E>Defense Acquisition Regulations System, Attn: Ms. Meredith Murphy, OUSD (AT&amp;L) DPAP/DARS, Room 3B855, 3060 Defense Pentagon, Washington, DC 20301-3060.</P>

            <P>Comments received generally will be posted without change to<E T="03">http://www.regulations.gov,</E>including any personal information provided. To confirm receipt of your comment(s), please check<E T="03">http://www.regulations.gov</E>approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).</P>
          </ADD>
          <FURINF>
            <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
            <P>Ms. Meredith Murphy, Defense Acquisition Regulations System, OUSD (AT&amp;L) DPAP/DARS, 3060 Defense Pentagon, Room 3B855, Washington, DC 20301-3060. Telephone 703-602-1302; facsimile 703-602-0350. Please cite DFARS Case 2010-D020.</P>
          </FURINF>
        </PREAMB>
        <SUPLINF>
          <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
          <HD SOURCE="HD1">I. Background</HD>
          <HD SOURCE="HD2">A. Statutory Requirements</HD>
          <P>The principal statutory restrictions concerning post-government employment for DoD and other Federal employees after leaving Government employment are found in 18 U.S.C. 207 and 41 U.S.C. 2104 (formerly, 41 U.S.C. 423), and 5 CFR parts 2637 and 2641.</P>
          <HD SOURCE="HD3">1. 18 U.S.C. 207</HD>
          <P>18 U.S.C. 207 prohibits an individual from representing a contractor to their former agency on particular matters involving specific parties that they handled while working for the Federal Government for defined cooling-off periods that vary according to the former official's involvement and position:</P>
          <P>a. Former personnel are permanently barred from representing their new employer to their former agencies for matters on which they were personally and substantially involved.</P>
          <P>b. Even if the former officials were not directly involved in the matter, former personnel may not represent their new employer to their former agency on matters that were pending under their official responsibility in their last year of service for two years after leaving Federal service.</P>
          <P>c. Former senior-level officers and employees may not contact their former agency on particular government matters that are pending or are of substantial interest to the former agency for one year after leaving Federal service.</P>
          <HD SOURCE="HD3">2. 41 U.S.C. 2104 (Formerly, 41 U.S.C. 423)</HD>
          <P>DoD and other Government acquisition officials may not accept compensation from a defense contractor during a one year cooling-off period if the official performed certain duties at DoD involving the contractor and a contract valued in excess of $10 million. However, the individual may accept employment from a division or affiliate that does not produce the same or similar items.</P>
          <HD SOURCE="HD3">3. Section 847 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2008</HD>
          <P>Section 847 requires that senior DoD officials who have been personally and substantially involved in contracts over $10 million request a written post-employment ethics opinion before receiving compensation from a contractor. It also applies to the employees who are affected by the one-year compensation ban of 41 U.S.C. 2104.</P>
          <HD SOURCE="HD2">B. Current Acquisition Regulations</HD>
          <P>1. FAR 3.104 implements 41 U.S.C 2104 and 18 U.S.C. 207.</P>
          <P>2. DFARS 203.104 implements procurement integrity for DoD.</P>
          <P>3. DFARS 203.171-3 is an implementation of section 847 of the NDAA for FY 2008. Pursuant to DFARS 203.171-3, defense contractors may not knowingly provide compensation to “covered DoD officials” (as defined by a January 2009 DFARS Clause 252.203-7000, Requirements Relating to Compensation of Former DoD Officials) who left Government employment on or after January 28, 2008, unless the contractor first determines that the former employee has received, or has requested at least 30 days prior to receiving compensation from the contractor, the post-employment ethics opinion regarding post-employment restrictions. DFARS 252.203-7000 incorporates this prohibition of knowingly compensating former DoD “covered officials,” into DoD contracts. The DFARS does not require additional action from the DoD contractor or covered employee in the event that the covered employee has not received an opinion on post-employment restrictions. In addition, the clause does not cover DoD employees who left the Government prior to January 28, 2008.</P>
          <HD SOURCE="HD2">C. General Accountability Office (GAO) Study GAO-08-485</HD>
          <P>Congress included a provision in the National Defense Authorization Act for Fiscal Year 2007 (Pub. L. 109-364, section 851) requiring GAO to report on recent employment of former DoD Officials by major defense contractors. In May 2008, the GAO issued a report, “Defense Contracting: Post-Government Employment of Former DoD Officials Needs Greater Transparency” (GAO-08-485). GAO auditors focused on 52 major defense contractors.</P>
          <P>The GAO found that contractors under-reported the employment of former DoD officials to the extent that they employed almost twice as many they reported.</P>
          <P>GAO estimated that approximately 422 former DoD officials (post-Government employment) were working on defense contracts under the responsibility of their former agency. At least nine of those individuals could have been performing services under the same contract for which they had prior program responsibility. GAO concluded that the results of the study indicated that defense contractors may employ a substantial number of former DoD officials on assignments related to their former positions.</P>
          <P>According to GAO, DoD does not have a mechanism for monitoring former senior officials and acquisition officials when they begin their new jobs with defense contractors. DoD's practice of providing written ethics opinions to senior and acquisition officials who request them provides only limited transparency, although DoD is in the process of implementing a single database for collecting and retaining this information.</P>
          <P>The GAO report showed that major defense contractors are not currently ensuring that former DoD senior officials and acquisition executives working on contracts are in compliance with post-employment restrictions. GAO concluded that greater transparency is needed by DoD with respect to former senior and acquisition executives (i.e., DoD “covered officials”) to ensure compliance with applicable post-employment restrictions.</P>
          <HD SOURCE="HD2">D. Proposed Rule</HD>

          <P>The proposed provision will remedy this deficiency by requiring offerors to submit representations at the time of contract award that all former DoD officials that are covered by the Procurement Integrity Act are in compliance with post-employment restrictions set forth in DFARS 203.171-3 and DFARS 252.203-7000. The<PRTPAGE P="32848"/>representation goes further in also requiring a representation that former DoD employees employed by the contractor are also in compliance with additional post-employment restrictions of 18 U.S.C. 207 and 5 CFR parts 2637 and 2631, including FAR 3.104-2.</P>
          <P>This representation will be required in contracts for commercial items. This representation is an enforcement mechanism for DFARS clause 252.203-7000, which is required in contracts for commercial items (see 252.212-7001(b)(1)). Therefore, the representation has been added to 252.212-7000.</P>
          <HD SOURCE="HD1">II. Executive Orders 12866 and 13563</HD>
          <P>Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.</P>
          <HD SOURCE="HD1">III. Regulatory Flexibility Act</HD>

          <P>DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,<E T="03">et seq.</E>Nevertheless, an initial regulatory flexibility analysis has been prepared, and is summarized as follows:</P>
          <P>This proposed rule is in response to a study by the General Accountability Office, “Defense Contracting: Post-Government Employment of Former DoD Officials Needs Greater Transparency” (GAO-08-485), issued in May 2008. The GAO found that contractors under-reported the employment of former DoD officials to the extent that they employed almost twice as many as they reported. The GAO report showed that major defense contractors are not currently ensuring that former DoD senior officials and acquisition executives working on contracts are in compliance with post-employment restrictions.</P>
          <P>The objective of the proposed rule is to remedy this deficiency reported by the GAO by requiring offerors to submit representations at the time of contract award that all former DoD officials that are covered by the Procurement Integrity Act are in compliance with post-employment restrictions set forth in DFARS 203.171-3 and DFARS 252.203-7000, as required by section 847 of the National Defense Authorization Act for Fiscal Year 2008. The representation goes further in also requiring a representation that former DoD employees employed by the contractor are also in compliance with additional post-employment restrictions of 18 U.S.C. 207 and 5 CFR parts 2637 and 2631, including FAR 3.104-2.</P>
          <P>The rule requires a representation from all offerors that respond to a DoD solicitation. However, the representation will only require preparatory effort if the offeror employs or otherwise provides compensation to former DoD officials covered by the Procurement Integrity Act. There is no impact on the offeror unless the former DoD officials covered by the Procurement Integrity Act are not in compliance with the post-employment restrictions. A covered DoD official is already defined in the clause at DFARS 252.203-7000, Requirements Relating to Compensation of Former DoD Employees. In the period of 2001-2006, 1.85 million former military and civilian personnel left DoD service. A “covered DoD official” only includes former DoD officials holding certain positions and who left within the past two years. The GAO found that the 1.85 million personnel who had left DoD service over a six-year period included only 35,192 who had served in the type of senior or acquisition official positions that made them subject to post-government employment restrictions, if they were subsequently hired by defense contractors. Dividing by 35,192 (to reduce the six-year period to a two-year period), we estimate that 11,730 of those officials would have left within the last two years. We estimate that 7,635 of these former officials may accept employment with a defense contractor (about 65 percent). The GAO study found 2,435 of these covered officials employed by 52 major defense contractors. Of the remaining 5,200 former officials covered by the Procurement Integrity Act, we estimate that 3,900 (75 percent) of them may work for small business concerns.</P>
          <P>There is no information collection requirement associated with this proposed rule. Offerors make the representation by submission of an offer. They are not allowed to submit an offer if they can not make the representation. In order to submit an offer, small entities that hire a former DoD official covered by the Procurement Integrity Act will have to check the compliance of such employees with various applicable post-employment restrictions. DFARS 252.203-7000, Requirements Relating to Compensation of Former DoD Officials, already requires contractors to determine that a covered DoD official has sought and received, or has not received after 30 days of seeking, a written opinion from the appropriate DoD ethics counselor, regarding the applicability of post-employment restrictions to the activities that the official is expected to undertake on behalf of the contractor. Therefore, this representation of compliance does not impose an additional burden on the offeror.</P>
          <P>The rule does not duplicate, overlap, or conflict with any other Federal rules.</P>
          <P>There are no known significant alternatives to the rule that would achieve the objectives of the rule.</P>
          <P>DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.</P>
          <P>DoD will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2010-D020) in correspondence.</P>
          <HD SOURCE="HD1">IV. Paperwork Reduction Act</HD>
          <P>The rule does not impose any new information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).</P>
          <LSTSUB>
            <HD SOURCE="HED">List of Subjects in 48 CFR Parts 203 and 252</HD>
            <P>Government procurement.</P>
          </LSTSUB>
          <SIG>
            <NAME>Ynette R. Shelkin,</NAME>
            <TITLE>Editor, Defense Acquisition Regulations System.</TITLE>
          </SIG>
          
          <P>Therefore, 48 CFR parts 203, 204, and 252 are proposed to be amended as follows:</P>
          <P>1. The authority citation for 48 CFR parts 203, 204, and 252 continues to read as follows:</P>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>41 U.S.C. 1303 and 48 CFR chapter 1.</P>
          </AUTH>
          <PART>
            <HD SOURCE="HED">PART 203—IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST</HD>
            <P>2. Revise section 203.171-4 to read as follows:</P>
            <SECTION>
              <PRTPAGE P="32849"/>
              <SECTNO>203.171-4</SECTNO>
              <SUBJECT>Solicitation provisions and contract clause.</SUBJECT>
              <P>(a) Use the clause at 252.203-7000, Requirements Relating to Compensation of Former DoD Officials, in all solicitations and contracts.</P>
              <P>(b) Use the provision at 252.203-70XX, Representation Relating to Compensation of Former DoD Officials, in all solicitations.</P>
            </SECTION>
          </PART>
          <PART>
            <HD SOURCE="HED">PART 204—ADMINISTRATIVE MATTERS</HD>
            <P>3. Amend section 204.1202 by redesignating paragraphs (2)(i) through (xii) as paragraphs (2)(ii) through (xiii) and adding new paragraph (2)(i) to read as follows,</P>
            <SECTION>
              <SECTNO>204.1202</SECTNO>
              <SUBJECT>Solicitation provision and contract clause.</SUBJECT>
              <STARS/>
              <P>(2) * * *</P>
              <P>(i) 252.203-70XX, Representation Relating to Compensation of Former DoD Officials.</P>
              <STARS/>
            </SECTION>
          </PART>
          <PART>
            <HD SOURCE="HED">PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
            <P>4. Add section 252.203-70XX to read as follows:</P>
            <SECTION>
              <SECTNO>252.203-70XX</SECTNO>
              <SUBJECT>Representation Relating to Compensation of Former DoD Officials.</SUBJECT>
              <P>As prescribed in 203.171-4(b), insert the following provision:</P>
              <HD SOURCE="HD1">REPRESENTATION RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (DATE)</HD>
              <EXTRACT>
                <P>(a)<E T="03">Definition. Covered DoD official</E>is defined in the clause at 252.203-7000, Requirements Relating to Compensation of Former DoD Officials.</P>
                <P>(b) By submission of this offer, the offeror represents, to the best of its knowledge and belief, that all covered DoD officials employed by or otherwise receiving compensation from the offeror are presently in compliance with—</P>
                <P>(1) Defense Federal Acquisition Regulation Supplement (DFARS) 203.171-3 and DFARS 252.203-7000; and</P>
                <P>(2) Other post-employment restrictions covered by 18 U.S.C. 207 and 5 CFR parts 2637 and 2631, including Federal Acquisition Regulation 3.104-2.</P>
              </EXTRACT>
              
              <P>(End of provision)</P>
              <P>5. Amend section 252.212-7000 by revising the clause date, revising paragraph (a), and adding paragraph (d) to read as follows:</P>
            </SECTION>
            <SECTION>
              <SECTNO>252.212-7000</SECTNO>
              <SUBJECT>Offeror Representations and Certifications—Commercial Items.</SUBJECT>
              <EXTRACT>
                <STARS/>
                <HD SOURCE="HD1">OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (JUN 2011)</HD>
                <P>(a)<E T="03">Definitions.</E>As used in this clause—</P>
                <P>
                  <E T="03">Covered DoD official</E>is defined in the clause at 252.203-7000, Requirements Relating to Compensation of Former DoD Officials.<E T="03">Foreign person</E>means any person other than a United States person as defined in Section 16(2) of the Export Administration Act of 1979 (50 U.S.C. App. Sec. 2415).</P>
                <P>
                  <E T="03">United States</E>means the 50 States, the District of Columbia, outlying areas, and the outer Continental Shelf as defined in 43 U.S.C. 1331.</P>
                <P>
                  <E T="03">United States person</E>is defined in section 16(2) of the Export Administration Act of 1979 and means any United States resident or national (other than an individual resident outside the United States and employed by other than a United States person), any domestic concern (including any permanent domestic establishment of any foreign concern), and any foreign subsidiary or affiliate (including any permanent foreign establishment) of any domestic concern which is controlled in fact by such domestic concern, as determined under regulations of the President.</P>
                <STARS/>
                <P>(d)<E T="03">Representation Relating to Compensation of Former DoD Officials.</E>By submission of this offer, the offeror represents, to the best of its knowledge and belief, that all covered DoD officials employed by or otherwise receiving compensation from the offeror, are presently in compliance with—</P>
                <P>(1) Defense Federal Acquisition Regulation Supplement (DFARS) 203.171-3 and DFARS 252.203-7000, Requirements Relating to Compensation of Former DoD Officials; and</P>
                <P>(2) Other post-employment restrictions covered by 18 U.S.C. 207 and 5 CFR parts 2637 and 2631, including Federal Acquisition Regulation 3.104-2.</P>
              </EXTRACT>
              
              <P>(End of provision)</P>
              
            </SECTION>
          </PART>
        </SUPLINF>
        <FRDOC>[FR Doc. 2011-13365 Filed 6-3-11; 8:45 am]</FRDOC>
        <BILCOD>BILLING CODE 5001-08-P</BILCOD>
      </PRORULE>
    </PRORULES>
  </NEWPART>
</FEDREG>

