,in the ,senate of the ,united ,states1 ,september #bi1 #bjbb4 ,amendment3 ,that the bill from the ,house of ,representatives 7,h4,r4 #fhcc7 entitled ,an ,act to amend title ,,xxvii of the ,public ,health ,service ,act1 the ,internal ,revenue ,code of #aihf1 and the ,employee ,retirement ,income ,security ,act of #aigd to establish requirements with respect to cost-sharing for certain insulin products1 and for other purposes41 do pass with the following ,strike all after the enacting clause and insert the following3 #a4 ,short title ,this ,act may be cited as the ,continuing ,appropriations and ,ukraine ,supplemental ,appropriations ,act1 #bjbc4 #b4 ,table of ,contents ,sec4 #a4 ,short ,title4,sec4 #b4 ,table of ,contents4,sec4 #c4 ,references4,sec4 #d4 ,payment to ,widows and ,heirs of ,deceased ,members of ,congress4 ,division ,a--,continuing ,appropriations ,act1 #bjbc;,division ,b--,ukraine ,supplemental ,appropriations ,act1 #bjbc;,division ,c--,other ,matters,title ,i--,extensions1 ,technical ,corrections1 and ,other ,matters,title ,,ii--,budgetary ,effects,division ,d--,health and ,human ,services ,extensions,title ,i--,medicare and ,medicaid,title ,,ii--,human ,services,title ,,iii--,public ,health,title ,,iv--,indian ,health,division ,e--,veterans ,affairs ,extensions ,title ,i--,extensions of authorities relating to health care,title ,,ii--,extensions of authorities relating to benefits,title ,,iii--,extensions of authorities relating to homeless veterans,title ,,iv--,extensions of other authorities,division ,f--,,fda ,user ,fee ,reauthorization ,act of #bjbb;,division ,g--,hermit's ,peak_/,calf ,canyon ,fire ,assistance ,act #c4 ,references ,except as expressly provided otherwise1 any reference to this ,act contained in any division of this ,act shall be treated as referring only to the provisions of that division4 #d4 ,payment to ,widows and ,heirs of ,deceased ,members of ,congress ,there is hereby appropriated for fiscal year #bjbc1 out of any money in the ,treasury not otherwise appropriated1 for payment to ,dean ,swihart1 beneficiary of ,jacqueline ,walorski-,swihart1 late a ,representative from the ,state of ,indiana1 #agd1jjj4 ,a ,continuing ,appropriations ,act1 #bjbc ,the following sums are hereby appropriated1 out of any money in the ,treasury not otherwise appropriated1 and out of applicable corporate or other revenues1 receipts1 and funds1 for the several departments1 agencies1 corporations1 and other organizational units of ,government for fiscal year #bjbc1 and for other purposes1 namely3 #aja4 ,such amounts as may be necessary1 at a rate for operations as provided in the applicable appropriations ,acts for fiscal year #bjbb and under the authority and conditions provided in such ,acts1 for continuing projects or activities 7including the costs of direct loans and loan guarantees7 that are not otherwise specifically provided for in this ,act1 that were conducted in fiscal year #bjbb1 and for which appropriations1 funds1 or other authority were made available in the following appropriations ,acts3 7#a7 ,the ,agriculture1 ,rural ,development1 ,food and ,drug ,administration1 and ,related ,agencies ,appropriations ,act1 #bjbb 7division ,a of ,public ,law #aag-ajc71 except section #ghc1 and except that section #ghe shall be applied by substituting #abe1jjj1jjj for #bej1jjj1jjj4 7#b7 ,the ,commerce1 ,justice1 ,science1 and ,related ,agencies ,appropriations ,act1 #bjbb 7division ,b of ,public ,law #aag-ajc71 except section #eba7;c77#a74 7#c7 ,the ,department of ,defense ,appropriations ,act1 #bjbb 7division ,c of ,public ,law #aag-ajc74 7#d7 ,the ,energy and ,water ,development and ,related ,agencies ,appropriations ,act1 #bjbb 7division ,d of ,public ,law #aag-ajc74 7#e7 ,the ,financial ,services and ,general ,government ,appropriations ,act1 #bjbb 7division ,e of ,public ,law #aag-ajc71 except the matter under the heading ,postal ,regulatory ,commission in title ,v4 7#f7 ,the ,department of ,homeland ,security ,appropriations ,act1 #bjbb 7division ,f of ,public ,law #aag-ajc71 except sections #edd and #ede1 and including title ,,ii of division ,o of ,public ,law #aag-ajc4 7#g7 ,the ,department of the ,interior1 ,environment1 and ,related ,agencies ,appropriations ,act1 #bjbb 7division ,g of ,public ,law #aag-ajc74 7#h7 ,the ,departments of ,labor1 ,health and ,human ,services1 and ,education1 and ,related ,agencies ,appropriations ,act1 #bjbb 7division ,h of ,public ,law #aag-ajc71 and section #afb of division ,a of ,public ,law #aag-dc4 7#i7 ,the ,legislative ,branch ,appropriations ,act1 #bjbb 7division ,i of ,public ,law #aag-ajc71 and section #f in the matter preceding division ,a of ,public ,law #aag-ajc4 7#aj7 ,the ,military ,construction1 ,veterans ,affairs1 and ,related ,agencies ,appropriations ,act1 #bjbb 7division ,j of ,public ,law #aag-ajc74 7#aa7 ,the ,department of ,state1 ,foreign ,operations1 and ,related ,programs ,appropriations ,act1 #bjbb 7division ,k of ,public ,law #aag-ajc71 except the first proviso of section #gjfi7;e74 7#ab7 ,the ,transportation1 ,housing and ,urban ,development1 and ,related ,agencies ,appropriations ,act1 #bjbb 7division ,l of ,public ,law #aag-ajc74 #ajb4 7a7 ,no appropriation or funds made available or authority granted pursuant to section #aja for the ,department of ,defense shall be used for3 7#a7 the new production of items not funded for production in fiscal year #bjbb or prior years2 7#b7 the increase in production rates above those sustained with fiscal year #bjbb funds2 or 7#c7 the initiation1 resumption1 or continuation of any project1 activity1 operation1 or organization 7defined as any project1 subproject1 activity1 budget activity1 program element1 and subprogram within a program element1 and for any investment items defined as a ,p-#a line item in a budget activity within an appropriation account and an ,r-#a line item that includes a program element and subprogram element within an appropriation account7 for which appropriations1 funds1 or other authority were not available during fiscal year #bjbb4 7b7 ,no appropriation or funds made available or authority granted pursuant to section #aja for the ,department of ,defense shall be used to initiate multi-year procurements utilizing advance procurement funding for economic order quantity procurement unless specifically appropriated later4 #ajc4 ,appropriations made by section #aja shall be available to the extent and in the manner that would be provided by the pertinent appropriations ,act4 #ajd4 ,except as otherwise provided in section #ajb1 no appropriation or funds made available or authority granted pursuant to section #aja shall be used to initiate or resume any project or activity for which appropriations1 funds1 or other authority were not available during fiscal year #bjbb4 #aje4 ,appropriations made and authority granted pursuant to this ,act shall cover all obligations or expenditures incurred for any project or activity during the period for which funds or authority for such project or activity are available under this ,act4 #ajf4 ,unless otherwise provided for in this ,act or in the applicable appropriations ,act for fiscal year #bjbc1 appropriations and funds made available and authority granted pursuant to this ,act shall be available until whichever of the following first occurs3 7#a7 ,the enactment into law of an appropriation for any project or activity provided for in this ,act4 7#b7 ,the enactment into law of the applicable appropriations ,act for fiscal year #bjbc without any provision for such project or activity4 7#c7 ,december #af1 #bjbb4 #ajg4 ,expenditures made pursuant to this ,act shall be charged to the applicable appropriation1 fund1 or authorization whenever a bill in which such applicable appropriation1 fund1 or authorization is contained is enacted into law4 #ajh4 ,appropriations made and funds made available by or authority granted pursuant to this ,act may be used without regard to the time limitations for submission and approval of apportionments set forth in section #aeac of title #ca1 ,united ,states ,code1 but nothing in this ,act may be construed to waive any other provision of law governing the apportionment of funds4 #aji4 ,notwithstanding any other provision of this ,act1 except section #ajf1 for those programs that would otherwise have high initial rates of operation or complete distribution of appropriations at the beginning of fiscal year #bjbc because of distributions of funding to ,states1 foreign countries1 grantees1 or others1 such high initial rates of operation or complete distribution shall not be made1 and no grants shall be awarded for such programs funded by this ,act that would impinge on final funding prerogatives4 #aaj4 ,this ,act shall be implemented so that only the most limited funding action of that permitted in the ,act shall be taken in order to provide for continuation of projects and activities4 #aaa4 7a7 ,for entitlements and other mandatory payments whose budget authority was provided in appropriations ,acts for fiscal year #bjbb1 and for activities under the ,food and ,nutrition ,act of #bjjh1 activities shall be continued at the rate to maintain program levels under current law1 under the authority and conditions provided in the applicable appropriations ,act for fiscal year #bjbb1 to be continued through the date specified in section #ajf7c74 7b7 ,notwithstanding section #ajf1 obligations for mandatory payments due on or about the first day of any month that begins after ,october #bjbb but not later than #cj days after the date specified in section #ajf7c7 may continue to be made1 and funds shall be available for such payments4 #aab4 ,amounts made available under section #aja for civilian personnel compensation and benefits in each department and agency may be apportioned up to the rate for operations necessary to avoid furloughs within such department or agency1 consistent with the applicable appropriations ,act for fiscal year #bjbb1 except that such authority provided under this section shall not be used until after the department or agency has taken all necessary actions to reduce or defer non-personnel-related administrative expenses4 #aac4 ,funds appropriated by this ,act may be obligated and expended notwithstanding section #aj of ,public ,law #ia-fgb 7#bb ,u4,s4,c4 #bdab71 section #ae of the ,state ,department ,basic ,authorities ,act of #aief 7#bb ,u4,s4,c4 #bfhj71 section #cac of the ,foreign ,relations ,authorization ,act1 ,fiscal ,years #aiid and #aiie 7#bb ,u4,s4,c4 #fbab71 and section #ejd7;a77#a7 of the ,national ,security ,act of #aidg 7#ej ,u4,s4,c4 #cjid7;a77#a774 #aad4 ,each amount incorporated by reference in this ,act that was previously designated by the ,congress as an emergency requirement pursuant to sections #djja7;a77#a7 and #djja7;b7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 or as being for disaster relief pursuant to section #djje7;f7 of such concurrent resolution1 is designated as being an emergency requirement pursuant to section #djja7;a77#a7 of such concurrent resolution and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb1 or as being for disaster relief pursuant to section #a7;f7 of such ,house resolution1 respectively4 #aae4 7a7 ,rescissions or cancellations of discretionary budget authority that continue pursuant to section #aja in ,treasury ,appropriations ,fund ,symbols 7,,tafs7-- 7#a7 to which other appropriations are not provided by this ,act1 but for which there is a current applicable ,,tafs that does receive an appropriation in this ,act2 or 7#b7 which are no-year ,,tafs and receive other appropriations in this ,act1 may be continued instead by reducing the rate for operations otherwise provided by section #aja for such current applicable ,,tafs1 as long as doing so does not impinge on the final funding prerogatives of the ,congress4 7b7 ,rescissions or cancellations described in subsection 7a7 shall continue in an amount equal to the lesser of-- 7#a7 the amount specified for rescission or cancellation in the applicable appropriations ,act referenced in section #aja of this ,act2 or 7#b7 the amount of balances available1 as of ,october #a1 #bjbb1 from the funds specified for rescission or cancellation in the applicable appropriations ,act referenced in section #aja of this ,act4 7c7 ,no later than ,november #ba1 #bjbb1 the ,director of the ,office of ,management and ,budget shall provide to the ,committees on ,appropriations of the ,house of ,representatives and the ,senate a comprehensive list of the rescissions or cancellations that will continue pursuant to section #aja3 ,provided1 ,that the information in such comprehensive list shall be periodically updated to reflect any subsequent changes in the amount of balances available1 as of ,october #a1 #bjbb1 from the funds specified for rescission or cancellation in the applicable appropriations ,act referenced in section #aja1 and such updates shall be transmitted to the ,committees on ,appropriations of the ,house of ,representatives and the ,senate upon request4 #aaf4 ,amounts made available by section #aja for ,farm ,service ,agency--,agricultural ,credit ,insurance ,fund ,program ,account may be apportioned up to the rate for operations necessary to accommodate approved applications for direct and guaranteed farm ownership loans1 as authorized by #g ,u4,s4,c4 #aibb et seq4 #aag4 ,amounts made available by section #aja to the ,department of ,agriculture for ,rural ,business--,cooperative ,service--,rural ,microentrepreneur ,assistance ,program may be used for the costs of loans1 including the cost of modifying such loans1 as defined in section #ejb of the ,congressional ,budget ,act of #aigd1 under the same terms and conditions as authorized by section #cgi;,e of the ,consolidated ,farm and ,rural ,development ,act 7#g ,u4,s4,c4 #bjjhs74 #aah4 ,section #bfj of the ,agricultural ,marketing ,act of #aidf 7#g ,u4,s4,c4 #afcf;i7 and section #idb of the ,livestock ,mandatory ,reporting ,act of #aiii 7#g ,u4,s4,c4 #afce note2 ,public ,law #ajf-gh7 shall be applied by substituting the date specified in section #ajf7c7 of this ,act for ,september #cj1 #bjbb4 #aai4 ,amounts made available by section #aja to the ,department of ,commerce for ,economic ,development ,administration--,salaries and ,expenses may be apportioned up to the rate for operations necessary to maintain agency operations4 #abj4 ,amounts made available by section #aja for ,department of ,commerce--,national ,telecommunications and ,information ,administration--,salaries and ,expenses may be apportioned up to the rate for operations necessary to ensure continued oversight of public safety communications programs4 #aba4 ,in addition to amounts otherwise provided by section #aja1 for ,department of ,justice--,federal ,bureau of ,investigation--,salaries and ,expenses1 there is appropriated #ae1cjj1jjj1 for an additional amount for fiscal year #bjbc1 to remain available until ,september #cj1 #bjbc1 for investigative activities associated with ,afghan resettlement operations3 ,provided1 ,that such amount is designated by the ,congress as being for an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 #abb4 7a7 ,notwithstanding sections #aja and #ajf1 through ,september #cj1 #bjbc1 the ,secretary of ,defense may transfer up to #c1jjj1jjj1jjj from unobligated balances from amounts made available under the heading ,department of ,defense--,operation and ,maintenance--,overseas ,humanitarian1 ,disaster1 and ,civic ,aid in division ,c of ,public ,law #aag-dc and division ,b of ,public ,law #aag-gj to any appropriation account under the headings ,department of ,state and ,related ,agency--,department of ,state--,administration of ,foreign ,affairs1 ,bilateral ,economic ,assistance--,department of ,state--,migration and ,refugee ,assistance1 and ,bilateral ,economic ,assistance--,department of ,state--,united ,states ,emergency ,refugee and ,migration ,assistance ,fund for support of ,operation ,allies ,welcome or any successor operation3 ,provided1 ,that upon transfer1 such funds shall be merged with the appropriation to which such funds are transferred except that such funds may be made available for such purposes notwithstanding any requirement or limitation applicable to the appropriation to which transferred1 including sections #b7;c77#a7 and #b7;c77#b7 of the ,migration and ,refugee ,assistance ,act of #aifb with respect to the ,united ,states ,emergency ,refugee and ,migration ,assistance ,fund and in sections #d7;a7 and #d7;b7 of the ,state ,department ,basic ,authorities ,act of #aief with respect to funds transferred to the ,emergencies in the ,diplomatic and ,consular ,service account3 ,provided further1 ,that section #bbae of title #aj1 ,united ,states ,code1 shall not apply to a transfer of funds under this subsection3 ,provided further1 ,that the exercise of the authority of this subsection shall be subject to prior consultation with1 and the regular notification procedures of1 the ,committees on ,appropriations of the ,house of ,representatives and the ,senate3 ,provided further1 ,that any funds transferred pursuant to this subsection that were previously designated by the ,congress as an emergency requirement pursuant to the concurrent resolution on the budget are designated by the ,congress as being for an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 7b7 ,not later than ,november #a1 #bjbb and prior to any transfer of funds pursuant to subsection 7a71 the ,director of the ,office of ,management and ,budget shall provide to the ,committees on ,appropriations of the ,house of ,representatives and the ,senate a written report on ,operation ,allies ,welcome or any successor operation3 ,provided1 ,that such report shall describe the number and status of ,afghans residing at ,department of ,defense and ,department of ,state-managed facilities and any anticipated future arrivals at such facilities2 the strategy and plan1 including timeline1 for adjudicating and relocating all ,afghans residing at ,department of ,defense or overseas civilian facilities and for the transition of operations and responsibilities under ,operation ,allies ,welcome or any successor operation from the ,department of ,defense to the ,department of ,state during fiscal year #bjbc2 the activities and responsibilities assigned to each ,federal agency involved in such strategy and plan2 and a spend plan1 containing an estimate of the costs1 including additional construction and security costs1 to be incurred by each such agency for carrying out such strategy and plan1 and the sources of funds3 ,provided further1 ,that prior to the initial obligation of funds transferred to the ,department of ,state pursuant to subsection 7a71 the ,secretary of ,state shall submit a report to such ,committees detailing the roles and responsibilities of ,department of ,state bureaus and offices in ,operation ,allies ,welcome or any successor operation4 #abc4 ,during the period covered by this ,act1 section #gad7;b77#b77;,b7 of title #aj1 ,united ,states ,code1 shall be applied by substituting three years for two years4 #abd4 7a7 ,of the remaining unobligated balances1 as of ,september #cj1 #bjbb1 from amounts provided under the heading ,afghanistan ,security ,forces ,fund in title ,,ix of division ,c of ,public ,law #aaf-bfj1 #ajj1jjj1jjj is hereby permanently rescinded1 and in addition to amounts otherwise provided by section #aja1 an amount of additional new budget authority equivalent to the amount rescinded pursuant to this subsection is hereby appropriated on ,september #cj1 #bjbb1 for an additional amount for fiscal year #bjbb1 to remain available until ,september #cj1 #bjbe1 for the same purposes and under the same authorities provided under such heading in ,public ,law #aaf-bfj1 in addition to other funds as may be available for such purposes4 7b7 7#a7 ,subject to paragraph 7#b71 this section shall become effective immediately upon enactment of this ,act4 7#b7 ,if this ,act is enacted after ,september #cj1 #bjbb1 this section shall be applied as if it were in effect on ,september #cj1 #bjbb4 #abe4 ,in addition to amounts otherwise provided by section #aja1 for ,corps of ,engineers--,civil--,construction1 there is appropriated #bj1jjj1jjj1 for an additional amount for fiscal year #bjbc1 to remain available until expended1 for necessary expenses related to water and wastewater infrastructure under section #bai of the ,water ,resources ,development ,act of #aiib 7#ajf ,stat4 #dhce73 ,provided1 ,that such amount is designated by the ,congress as being for an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 #abf4 7a7 ,during the period covered by this ,act1 title ,i of ,public ,law #ajh-cfa 7the ,calfed ,bay-,delta ,authorization ,act7 7#aah ,stat4 #afha71 as amended by section #bjd of division ,d of ,public ,law #aag-ajc1 shall be applied by substituting #bjbc for #bjbb each place it appears4 7b7 ,during the period covered by this ,act1 section #ajc7;f77#d77;,a7 of title ,i of ,public ,law #ajh-cfa 7the ,calfed ,bay-,delta ,authorization ,act7 7#aah ,stat4 #afif7 shall be applied by substituting #be1fej1jjj for #be1jjj1jjj4 #abg4 7a7 ,during the period covered by this ,act1 section #iajf7;g77#b7 of ,public ,law #aaa-aa 7,omnibus ,public ,land ,management ,act of #bjji7 shall be applied by substituting #bjbc for #bjbb4 7b7 ,during the period covered by this ,act1 section #ajd7;c7 of the ,reclamation ,states ,emergency ,drought ,relief ,act of #aiia 7#dc ,u4,s4,c4 #bbad7;c77 shall be applied by substituting #bjbc for #bjbb4 7c7 ,during the period covered by this ,act1 section #cja of the ,reclamation ,states ,emergency ,drought ,relief ,act of #aiia 7#dc ,u4,s4,c4 #bbda7 shall be applied by substituting #bjbc for #bjbb4 #abh4 ,in addition to amounts otherwise provided by section #aja1 amounts are provided for ,department of the ,treasury--,alcohol and ,tobacco ,tax and ,trade ,bureau--,salaries and ,expenses at a rate for operations of #ad1ibi1jjj1 for an additional amount to administer the ,craft ,beverage ,modernization ,act import claims program1 as required by the ,taxpayer ,certainty and ,disaster ,tax ,relief ,act of #bjbj1 and such amounts may be apportioned up to the rate for operations necessary to establish and implement a new import claims program4 #abi4 ,notwithstanding section #aja1 title ,,ii of division ,e of ,public ,law #aag-ajc shall be applied by adding the following new heading and appropriation language under the heading 8,executive ,office of the ,president and ,funds ,appropriated to the ,president03 ,office of the ,national ,cyber ,director ,salaries and ,expenses ,for necessary expenses of the ,office of the ,national ,cyber ,director1 as authorized by section #ageb of the ,william ,m4 7,mac7 ,thornberry ,national ,defense ,authorization ,act for ,fiscal ,year #bjba 7,public ,law #aaf-bhc71 #ba1jjj1jjj1 of which not to exceed #e1jjj shall be available for official reception and representation expenses4 4 #acj4 ,notwithstanding section #aja1 amounts are provided for ,the ,judiciary--,courts of ,appeals1 ,district ,courts1 and ,other ,judicial ,services--,fees of ,jurors and ,commissioners at a rate for operations of #ei1efe1jjj4 #aca4 ,in addition to amounts otherwise provided by section #aja1 for ,the ,judiciary--,courts of ,appeals1 ,district ,courts1 and ,other ,judicial ,services--,court ,security1 there is appropriated #aab1ejj1jjj1 for an additional amount for fiscal year #bjbc1 to remain available until expended1 for security improvements at ,united ,states courthouses and ,federal court facilities3 ,provided1 ,that not later than #ij days after the date of enactment of this ,act1 and every #ij days thereafter until all funds provided by this section have been expended1 the ,director of the ,administrative ,office of the ,united ,states ,courts shall provide1 in an appropriate format1 quarterly reports on the obligations and expenditures of the funds provided under this section to the ,committees on ,appropriations of the ,house of ,representatives and the ,senate3 ,provided further1 ,that such amount is designated by the ,congress as being for an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 #acb4 ,notwithstanding any other provision of this ,act1 except section #ajf1 the ,district of ,columbia may expend local funds made available under the heading ,district of ,columbia--,district of ,columbia ,funds for such programs and activities under the ,district of ,columbia ,appropriations ,act1 #bjbb 7title ,,iv of division ,e of ,public ,law #aag-ajc7 at the rate set forth in the ,fiscal ,year #bjbc ,local ,budget ,act of #bjbb 7,d4,c4 ,act #bd-dhf71 as modified as of the date of enactment of this ,act4 #acc4 ,in addition to amounts otherwise provided by section #aja1 amounts are provided for ,small ,business ,administration--,salaries and ,expenses at a rate for operations of #bj1jjj1jjj1 for an additional amount for costs associated with the establishment and implementation of a ,government-wide service-disabled veteran-owned small business certification program within the ,small ,business ,administration1 as required by section #cf of the ,small ,business ,act 7#ae ,u4,s4,c4 #feg;f7 and section #hfb of ,public ,law #aaf-bhc3 ,provided1 ,that such amounts may be apportioned up to the rate for operations necessary to establish and implement such certification program3 ,provided further1 ,that such amounts may be obligated in the account and budget structure set forth in ,h4,r4 #hbid1 as passed by the ,house of ,representatives on ,july #bj1 #bjbb4 #acd4 ,amounts made available by section #aja for ,small ,business ,administration--,business ,loans ,program ,account may be apportioned up to the rate for operations necessary to accommodate increased demand for commitments for general business loans authorized under paragraphs 7#a7 through 7#ce7 of section #g7;a7 of the ,small ,business ,act 7#ae ,u4,s4,c4 #fcf7;a771 for guarantees of trust certificates authorized by section #e7;g7 of the ,small ,business ,act 7#ae ,u4,s4,c4 #fcd7;g771 for commitments to guarantee loans under section #ejc of the ,small ,business ,investment ,act of #aieh 7#ae ,u4,s4,c4 #fig71 and for commitments to guarantee loans for debentures under section #cjc7;b7 of the ,small ,business ,investment ,act of #aieh 7#ae ,u4,s4,c4 #fhc7;b774 #ace4 ,amounts made available by section #aja to the ,department of ,homeland ,security under the heading ,federal ,emergency ,management ,agency--,disaster ,relief ,fund may be apportioned up to the rate for operations necessary to carry out response and recovery activities under the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act 7#db ,u4,s4,c4 #eaba et seq474 #acf4 ,notwithstanding sections #aja1 #ajd1 and #ajf1 to carry out the ,hermit's ,peak_/,calf ,canyon ,fire ,assistance ,act1 there is appropriated #b1ejj1jjj1jjj1 to remain available until expended1 to the ,department of ,homeland ,security for ,federal ,emergency ,management ,agency--,hermit's ,peak_/,calf ,canyon ,fire ,assistance ,account1 which shall be derived by transfer from amounts made available under the heading ,federal ,emergency ,management ,agency--,disaster ,relief ,fund in title ,,vi of division ,b of the ,coronavirus ,aid1 ,relief1 and ,economic ,security ,act 7,public ,law #aaf-acf71 of which #a1jjj1jjj shall be transferred to ,office of the ,inspector ,general--,operations and ,support for oversight of activities authorized by the ,hermit's ,peak_/,calf ,canyon ,fire ,assistance ,act3 ,provided1 ,that no amounts may be derived from amounts made available for major disasters declared pursuant to the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act 7#db ,u4,s4,c4 #eaba et seq473 ,provided further1 ,that amounts provided by this section shall be subject to the same authorities and conditions as if such amounts were provided by title ,,iii of the ,department of ,homeland ,security ,appropriations ,act1 #bjbb 7division ,f of ,public ,law #aag-ajc73 ,provided further1 ,that not later than #ij days after the date of enactment of this ,act1 and every #ij days thereafter until all funds provided by this section have been expended1 the ,administrator of the ,federal ,emergency ,management ,agency shall provide1 in an appropriate format1 quarterly reports to the ,committees on ,appropriations of the ,senate and the ,house of ,representatives on the obligations and expenditures of the funds made available by this section3 ,provided further1 ,that amounts transferred by this section that were previously designated by the ,congress as an emergency requirement pursuant to the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe or a concurrent resolution on the budget are designated as an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 #acg4 ,section #gjh7;b77#ac7 of the ,homeland ,security ,act of #bjjb 7#f ,u4,s4,c4 #cdh7;b77#ac77 shall be applied by substituting the date specified in section #ajf7c7 of this ,act for ,september #cj1 #bjbb4 #ach4 ,during the period covered by this ,act1 section #hbb7;a7 of the ,homeland ,security ,act of #bjjb 7#f ,u4,s4,c4 #chc7;a77 shall be applied by substituting #bjbc for #bjbb4 #aci4 7a7 ,sections #acji7;a7 and #acai of the ,national ,flood ,insurance ,act of #aifh 7#db ,u4,s4,c4 #djaf7;a7 and #djbf7 shall be applied by substituting the date specified in section #ajf7c7 of this ,act for ,september #cj1 #bjbb4 7b7 7#a7 ,subject to paragraph 7#b71 this section shall become effective immediately upon enactment of this ,act4 7#b7 ,if this ,act is enacted after ,september #cj1 #bjbb1 this section shall be applied as if it were in effect on ,september #cj1 #bjbb4 #adj4 ,section #hhj7;g7 of the ,national ,defense ,authorization ,act for ,fiscal ,year #bjag 7,public ,law #aad-cbh7 shall be applied by substituting the date specified in section #ajf7c7 of this ,act for ,september #cj1 #bjbb4 #ada4 ,section #baj;,g7i7 of the ,homeland ,security ,act of #bjjb 7#f ,u4,s4,c4 #abdn7i77 shall be applied by substituting the date specified in section #ajf7c7 of this ,act for the date that is #d years after the date of enactment of this section4 #adb4 ,amounts made available by section #aja for ,department of the ,interior--,national ,park ,service--,national ,recreation and ,preservation for heritage partnership programs may be used to provide financial assistance to any national heritage area1 national heritage corridor1 cultural heritage corridor1 national heritage partnership1 national heritage route1 national heritage canalway1 and battlefields national historic district established as of ,september #a1 #bjbb1 notwithstanding any statutory sunset provision terminating the ,secretary's authority to provide assistance to any such area and notwithstanding any limitation on amounts authorized to be appropriated with respect to any such area4 #adc4 ,amounts made available by section #aja to the ,department of the ,interior under the heading ,working ,capital ,fund may be apportioned up to the rate for operations necessary to implement enterprise cybersecurity safeguards4 #add4 7a7 ,in addition to amounts otherwise provided by section #aja1 amounts are provided for ,department of ,health and ,human ,services--,indian ,health ,service--,indian ,health ,services at a rate for operations of #af1gba1jjj1 for an additional amount for costs of staffing and operating facilities that were opened1 renovated1 or expanded in fiscal years #bjbb and #bjbc1 and such amounts may be apportioned up to the rate for operations necessary to staff and operate such facilities4 7b7 ,in addition to amounts otherwise provided by section #aja1 amounts are provided for ,department of ,health and ,human ,services--,indian ,health ,service--,indian ,health ,facilities at a rate for operations of #a1bja1jjj1 for an additional amount for costs of staffing and operating facilities that were opened1 renovated1 or expanded in fiscal years #bjbb and #bjbc1 and such amounts may be apportioned up to the rate for operations necessary to staff and operate such facilities4 #ade4 ,in addition to amounts otherwise provided by section #aja1 for ,department of ,health and ,human ,services--,substance ,abuse and ,mental ,health ,services ,administration--,mental ,health1 there is appropriated #fb1jjj1jjj1 for an additional amount for fiscal year #bjbc1 to remain available until ,september #cj1 #bjbc1 for carrying out #ihh ,suicide ,lifeline activities and behavioral health crisis services4 #adf4 ,in addition to amounts otherwise provided by section #aja1 for ,department of ,health and ,human ,services--,administration for ,children and ,families--,low ,income ,home ,energy ,assistance1 there is appropriated #a1jjj1jjj1jjj1 for an additional amount for fiscal year #bjbc1 to remain available until ,september #cj1 #bjbc1 for making payments under subsection 7b7 of section #bfjb of the ,low-,income ,home ,energy ,assistance ,act of #aiha 7#db ,u4,s4,c4 #hfba et seq473 ,provided1 ,that of the funds made available by this section1 #ejj1jjj1jjj shall be allocated as though the total appropriation for such payments for fiscal year #bjbc was less than #a1ige1jjj1jjj3 ,provided further1 ,that such amount is designated by the ,congress as being for an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 #adg4 ,in addition to amounts otherwise provided by section #aja1 for ,department of ,health and ,human ,services--,administration for ,children and ,families--,refugee and ,entrant ,assistance1 there is appropriated #a1gge1jjj1jjj1 for an additional amount for fiscal year #bjbc1 to remain available until ,september #cj1 #bjbe1 to carry out section #dfb of the ,homeland ,security ,act of #bjjb and section #bce of the ,william ,wilberforce ,trafficking ,victims ,protection ,reauthorization ,act of #bjjh1 and for refugee and entrant assistance activities authorized by section #dad of the ,immigration and ,nationality ,act and section #eja of the ,refugee ,education ,assistance ,act of #aihj3 ,provided1 ,that such amount is designated by the ,congress as being for an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 #adh4 ,notwithstanding section #aja1 the first paragraph under the heading ,social ,security ,administration--,limitation on ,administrative ,expenses in title ,,iv of division ,h of ,public ,law #aag-ajc shall be applied by substituting #ac1fjb1ide1jjj for #ac1bjb1ide1jjj4 #adi4 7a7 ,during the period covered by this ,act1 subsection 7a77#a77;,a7 of section #bejb of the ,afghanistan ,supplemental ,appropriations ,act1 #bjbb 7division ,c of ,public ,law #aag-dc7 shall be applied by substituting the date specified in section #ajf7c7 for ,september #cj1 #bjbb4 7b7 ,the amount provided by this section is designated as an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 #aej4 ,activities authorized by part ,a of title ,,iv 7other than under section #djc7;c7 or #dah7 and section #aajh7;b7 of the ,social ,security ,act shall continue through the date specified in section #ajf7c71 in the manner authorized for fiscal year #bjbb1 and out of any money in the ,treasury of the ,united ,states not otherwise appropriated1 there are hereby appropriated such sums as may be necessary for such purpose4 #aea4 ,notwithstanding section #aja1 section #abf of division ,j of ,public ,law #aag-ajc shall be applied during the period covered by this ,act by substituting fiscal year #bjag and fiscal year #bjah for fiscal year #bjag4 #aeb4 ,notwithstanding section #aja1 amounts are provided for-- 7#a7 ,department of ,state and ,related ,agency--,department of ,state--,administration of ,foreign ,affairs--,diplomatic ,programs at a rate for operations of #i1bbh1ghi1jjj2 7#b7 ,bilateral ,economic ,assistance--,funds ,appropriated to the ,president--,international ,disaster ,assistance at a rate for operations of #d1eee1dfj1jjj2 7#c7 ,bilateral ,economic ,assistance--,funds ,appropriated to the ,president--,transition ,initiatives at a rate for operations of #ajj1jjj1jjj2 7#d7 ,bilateral ,economic ,assistance--,funds ,appropriated to the ,president--,assistance for ,europe1 ,eurasia and ,central ,asia at a rate for operations of #hej1jjj1jjj2 7#e7 ,bilateral ,economic ,assistance--,department of ,state--,migration and ,refugee ,assistance at a rate for operations of #c1efb1ahh1jjj2 7#f7 ,international ,security ,assistance--,department of ,state--,international ,narcotics ,control and ,law ,enforcement at a rate for operations of #a1dba1jjd1jjj2 and 7#g7 ,international ,security ,assistance--,funds ,appropriated to the ,president--,foreign ,military ,financing ,program at a rate for operations of #f1aij1dbd1jjj4 #aec4 ,during the period covered by this ,act1 section #egi of the ,multifamily ,assisted ,housing ,reform and ,affordability ,act of #aiig 7#db ,u4,s4,c4 #adcg;f note7 shall be applied by substituting #bjbc for #bjbb each place it appears4 #aed4 ,amounts made available by section #aja to the ,department of ,housing and ,urban ,development for ,public and ,indian ,housing--,native ,hawaiian ,housing ,loan ,guarantee ,fund ,program ,account may be apportioned up to the rate for operations necessary to accommodate demand for commitments to guarantee loans as authorized by section #ahd;,a of the ,housing and ,community ,development ,act of #aiib 7#ab ,u4,s4,c4 #agaez-#ac;b74 #aee4 ,in addition to amounts otherwise provided by section #aja1 for ,department of ,housing and ,urban ,development--,community ,planning and ,development--,community ,development ,fund1 there is appropriated #b1jjj1jjj1jjj1 for an additional amount for fiscal year #bjbc1 to remain available until expended1 for the same purposes and under the same terms and conditions as funds appropriated under such heading in title ,,viii of the ,disaster ,relief ,supplemental ,appropriations ,act1 #bjbb 7division ,b of ,public ,law #aag-dc71 except that such amounts shall be for major disasters that occurred in #bjba or #bjbb and the fourth1 twentieth1 and twenty-first provisos under such heading in such ,act shall not apply3 ,provided1 ,that amounts made available under this section and under such heading in such ,act may be used by a grantee to assist utilities as part of a disaster-related eligible activity under section #aje7;a7 of the ,housing and ,community ,development ,act of #aigd 7#db ,u4,s4,c4 #ecje7;a773 ,provided further1 ,that such amount is designated by the ,congress as being for an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 #aef4 ,notwithstanding section #ajf of this ,act1 at any time during fiscal year #bjbc1 the ,secretary of ,housing and ,urban ,development may transfer up to #a1cjj1jjj in unobligated balances from amounts made available in prior ,acts under the heading ,housing ,programs--,project-,based ,rental ,assistance to ,treasury ,appropriation ,fund ,symbol #hf ,x #jadh for the liquidation of obligations incurred in fiscal year #bjah in connection with the continued provision of interest reduction payments authorized under section #bcf of the ,national ,housing ,act 7#ab ,u4,s4,c4 #agaez-#a74 #aeg4 7a7 ,the remaining unobligated balances1 as of ,september #cj1 #bjbb1 from amounts made available for ,department of ,transportation--,office of the ,secretary--,national ,infrastructure ,investments in title ,i of division ,h of the ,further ,consolidated ,appropriations ,act1 #bjbj 7,public ,law #aaf-id7 are hereby permanently rescinded1 and in addition to amounts otherwise provided by section #aja1 an amount of additional new budget authority equivalent to the amount rescinded pursuant to this subsection is hereby appropriated on ,september #cj1 #bjbb1 for an additional amount for fiscal year #bjbb1 to remain available until ,september #cj1 #bjbc1 and shall be available1 without additional competition1 for completing the funding of awards made pursuant to the fiscal year #bjbj national infrastructure investments program1 in addition to other funds as may be available for such purposes4 7b7 ,the remaining unobligated balances1 as of ,september #cj1 #bjbb1 from amounts made available to the ,department of ,transportation in section #aje of division ,l of the ,consolidated ,appropriations ,act1 #bjba 7,public ,law #aaf-bfj7 are hereby permanently rescinded1 and in addition to amounts otherwise provided by section #aja1 an amount of additional new budget authority equivalent to the amount rescinded pursuant to this subsection is hereby appropriated on ,september #cj1 #bjbb1 for an additional amount for fiscal year #bjbb1 to remain available until ,september #cj1 #bjbc1 and shall be available1 without additional competition1 for completing the funding of awards made pursuant to the fiscal year #bjai national infrastructure investments program1 in addition to other funds as may be available for such purposes4 7c7 7#a7 ,subject to paragraph 7#b71 this section shall become effective immediately upon enactment of this ,act4 7#b7 ,if this ,act is enacted after ,september #cj1 #bjbb1 this section shall be applied as if it were in effect on ,september #cj1 #bjbb4 ,this division may be cited as the ,continuing ,appropriations ,act1 #bjbc4 ,b ,ukraine ,supplemental ,appropriations ,act1 #bjbc ,the following sums are appropriated1 out of any money in the ,treasury not otherwise appropriated1 for the fiscal year ending ,september #cj1 #bjbc1 and for other purposes1 namely3 ,i ,department of ,defense ,military ,personnel ,military ,personnel1 ,army ,for an additional amount for ,military ,personnel1 ,army1 #aaj1ajg1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,military ,personnel1 ,navy ,for an additional amount for ,military ,personnel1 ,navy1 #dfb1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,military ,personnel1 ,marine ,corps ,for an additional amount for ,military ,personnel1 ,marine ,corps1 #fjj1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,military ,personnel1 ,air ,force ,for an additional amount for ,military ,personnel1 ,air ,force1 #aa1ehb1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,operation and ,maintenance ,operation and ,maintenance1 ,army ,for an additional amount for ,operation and ,maintenance1 ,army1 #fed1fif1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,operation and ,maintenance1 ,navy ,for an additional amount for ,operation and ,maintenance1 ,navy1 #dcc1jce1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,operation and ,maintenance1 ,marine ,corps ,for an additional amount for ,operation and ,maintenance1 ,marine ,corps1 #cd1ihd1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,operation and ,maintenance1 ,air ,force ,for an additional amount for ,operation and ,maintenance1 ,air ,force1 #bfg1jhd1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,operation and ,maintenance1 ,space ,force ,for an additional amount for ,operation and ,maintenance1 ,space ,force1 #a1gga1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,operation and ,maintenance1 ,defense-,wide 7,including ,transfer of ,funds7 ,for an additional amount for ,operation and ,maintenance1 ,defense-,wide1 #d1gac1edd1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses3 ,provided1 ,that of the total amount provided under this heading in this ,act1 #c1jjj1jjj1jjj1 to remain available until ,september #cj1 #bjbd1 shall be for the ,ukraine ,security ,assistance ,initiative3 ,provided further1 ,that such funds for the ,ukraine ,security ,assistance ,initiative shall be available to the ,secretary of ,defense under the same terms and conditions as are provided for in section #haci of the ,department of ,defense ,appropriations ,act1 #bjbb 7division ,c of ,public ,law #aag-ajc73 ,provided further1 ,that of the total amount provided under this heading in this ,act1 up to #a1ejj1jjj1jjj1 to remain available until ,september #cj1 #bjbd1 may be transferred to accounts under the headings ,operation and ,maintenance and ,procurement for replacement of defense articles from the stocks of the ,department of ,defense1 and for reimbursement for defense services of the ,department of ,defense and military education and training1 provided to the government of ,ukraine or to foreign countries that have provided support to ,ukraine at the request of the ,united ,states3 ,provided further1 ,that funds transferred pursuant to a transfer authority provided under this heading in this ,act shall be merged with and available for the same purposes and for the same time period as the appropriations to which the funds are transferred3 ,provided further1 ,that the ,secretary of ,defense shall notify the congressional defense committees of the details of such transfers not less than #ae days before any such transfer3 ,provided further1 ,that upon a determination that all or part of the funds transferred from this appropriation are not necessary for the purposes provided herein1 such amounts may be transferred back and merged with this appropriation3 ,provided further1 ,that the transfer authority provided under this heading in this ,act is in addition to any other transfer authority provided by law4 ,procurement ,missile ,procurement1 ,army ,for an additional amount for ,missile ,procurement1 ,army1 #dej1jjj1jjj1 to remain available until ,september #cj1 #bjbe1 to respond to the situation in ,ukraine and for related expenses4 ,procurement of ,ammunition1 ,army ,for an additional amount for ,procurement of ,ammunition1 ,army1 #edj1jjj1jjj1 to remain available until ,september #cj1 #bjbe1 for expansion of public and private plants1 including the land necessary therefor1 and procurement and installation of equipment1 appliances1 and machine tools in such plants1 for the purpose of increasing production of critical munitions to replace defense articles provided to the ,government of ,ukraine or foreign countries that have provided support to ,ukraine at the request of the ,united ,states4 ,other ,procurement1 ,army ,for an additional amount for ,other ,procurement1 ,army1 #c1hij1jjj1 to remain available until ,september #cj1 #bjbe1 to respond to the situation in ,ukraine and for related expenses4 ,other ,procurement1 ,navy ,for an additional amount for ,other ,procurement1 ,navy1 #b1agj1jjj1 to remain available until ,september #cj1 #bjbe1 to respond to the situation in ,ukraine and for related expenses4 ,other ,procurement1 ,air ,force ,for an additional amount for ,other ,procurement1 ,air ,force1 #dcg1iia1jjj1 to remain available until ,september #cj1 #bjbe1 to respond to the situation in ,ukraine and for other expenses4 ,procurement1 ,defense-,wide ,for an additional amount for ,procurement1 ,defense-,wide1 #i1ggj1jjj1 to remain available until ,september #cj1 #bjbe1 to respond to the situation in ,ukraine and for related expenses4 ,research1 ,development1 ,test and ,evaluation ,research1 ,development1 ,test and ,evaluation1 ,army ,for an additional amount for ,research1 ,development1 ,test and ,evaluation1 ,army1 #c1cjj1jjj1 to remain available until ,september #cj1 #bjbd1 to respond to the situation in ,ukraine and for related expenses4 ,research1 ,development1 ,test and ,evaluation1 ,navy ,for an additional amount for ,research1 ,development1 ,test and ,evaluation1 ,navy1 #b1jgg1jjj1 to remain available until ,september #cj1 #bjbd1 to respond to the situation in ,ukraine and for related expenses4 ,research1 ,development1 ,test and ,evaluation1 ,air ,force ,for an additional amount for ,research1 ,development1 ,test and ,evaluation1 ,air ,force1 #ii1gjd1jjj1 to remain available until ,september #cj1 #bjbd1 to respond to the situation in ,ukraine and for related expenses4 ,research1 ,development1 ,test and ,evaluation1 ,defense-,wide ,for an additional amount for ,research1 ,development1 ,test and ,evaluation1 ,defense-,wide1 #ca1bcj1jjj1 to remain available until ,september #cj1 #bjbd1 to respond to the situation in ,ukraine and for related expenses4 ,other ,department of ,defense ,programs ,office of the ,inspector ,general ,for an additional amount for ,office of the ,inspector ,general1 #b1jjj1jjj1 to remain available until ,september #cj1 #bjbc1 to carry out reviews of the activities of the ,department of ,defense to execute funds appropriated in this title1 including assistance provided to ,ukraine3 ,provided1 ,that the ,inspector ,general of the ,department of ,defense shall provide to the congressional defense committees a briefing not later than #ij days after the date of enactment of this ,act4 ,related ,agencies ,intelligence ,community ,management ,account ,for an additional amount for ,intelligence ,community ,management ,account1 #ejj1jjj1 to remain available until ,september #cj1 #bjbc1 to respond to the situation in ,ukraine and for related expenses4 ,general ,provisions--,this ,title #aaja4 ,not later than #fj days after the date of enactment of this ,act1 the ,secretary of ,defense1 in coordination with the ,secretary of ,state1 shall submit a report to the ,committees on ,appropriations1 ,armed ,services1 and ,foreign ,affairs of the ,house of ,representatives and the ,committees on ,appropriations1 ,armed ,services1 and ,foreign ,relations of the ,senate on measures being taken to account for ,united ,states defense articles designated for ,ukraine since the ,february #bd1 #bjbb1 ,russian invasion of ,ukraine1 particularly measures with regard to such articles that require enhanced end-use monitoring2 measures to ensure that such articles reach their intended recipients and are used for their intended purposes2 and any other measures to promote accountability for the use of such articles3 ,provided1 ,that such report shall include a description of any occurrences of articles not reaching their intended recipients or used for their intended purposes and a description of any remedies taken3 ,provided further1 ,that such report shall be submitted in unclassified form1 but may be accompanied by a classified annex4 #aajb4 ,not later than #cj days after the date of enactment of this ,act1 and every #cj days thereafter through fiscal year #bjbc1 the ,secretary of ,defense1 in coordination with the ,secretary of ,state1 shall provide a written report to the ,committees on ,appropriations1 ,armed ,services1 and ,foreign ,affairs of the ,house of ,representatives and the ,committees on ,appropriations1 ,armed ,services1 and ,foreign ,relations of the ,senate describing ,united ,states security assistance provided to ,ukraine since the ,february #bd1 #bjbb1 ,russian invasion of ,ukraine1 including a comprehensive list of the defense articles and services provided to ,ukraine and the associated authority and funding used to provide such articles and services3 ,provided1 ,that such report shall be submitted in unclassified form1 but may be accompanied by a classified annex4 ,,ii ,department of ,energy ,atomic ,energy ,defense ,activities ,national ,nuclear ,security ,administration ,defense ,nuclear ,nonproliferation ,for an additional amount for ,defense ,nuclear ,nonproliferation1 #ce1jjj1jjj1 to remain available until expended1 to respond to the situation in ,ukraine and for related expenses4 ,,iii ,bilateral ,economic ,assistance ,funds ,appropriated to the ,president ,economic ,support ,fund ,for an additional amount for ,economic ,support ,fund1 #d1ejj1jjj1jjj1 to remain available until ,september #cj1 #bjbd1 for assistance for ,ukraine3 ,provided1 ,that funds appropriated under this heading in this ,act may be made available notwithstanding any other provision of law that restricts assistance to foreign countries and may be made available as contributions4 ,general ,provisions--,this ,title #acja4 ,during fiscal year #bjbc1 section #ejf7;a77#a7 of the ,foreign ,assistance ,act of #aifa 7#bb ,u4,s4,c4 #bcah7;a77#a77 shall be applied by substituting #c1gjj1jjj1jjj for #ajj1jjj1jjj4 #acjb4 7a7 ,funds appropriated by this title shall be made available for direct financial support for the ,government of ,ukraine1 including for ,ukrainian first responders1 and may be made available as a cash transfer subject to the requirements of subsection 7b73 ,provided1 ,that such funds shall be provided on a reimbursable basis and matched by sources other than the ,united ,states ,government1 to the maximum extent practicable3 ,provided further1 ,that the ,secretary of ,state or the ,administrator of the ,united ,states ,agency for ,international ,development1 as appropriate1 shall ensure third-party monitoring of such funds3 ,provided further1 ,that at least #ae days prior to the initial obligation of such funds1 the ,secretary of ,state1 following consultation with the ,administrator of the ,united ,states ,agency for ,international ,development1 shall certify and report to the appropriate congressional committees that mechanisms for monitoring and oversight of such funds are in place and functioning and that the ,government of ,ukraine has in place substantial safeguards to prevent corruption and ensure accountability of such funds3 ,provided further1 ,that not less than #de days after the initial obligation of such funds1 the ,inspectors ,general of the ,department of ,state and the ,united ,states ,agency for ,international ,development shall submit a report to the appropriate congressional committees detailing and assessing the mechanisms for monitoring and safeguards described in the previous proviso4 7b7 ,funds made available to the ,government of ,ukraine as a cash transfer under subsection 7a7 shall be subject to a memorandum of understanding between the ,governments of the ,united ,states and ,ukraine that describes how the funds proposed to be made available will be used and the appropriate safeguards to ensure transparency and accountability3 ,provided1 ,that such assistance shall be maintained in a separate1 auditable account and may not be comingled with any other funds4 7c7 ,the ,secretary of ,state or the ,administrator of the ,united ,states ,agency for ,international ,development1 as appropriate1 shall report to the appropriate congressional committees on the uses of funds provided for direct financial support to the ,government of ,ukraine pursuant to subsection 7a7 not later than #de days after the date of enactment of this ,act and every #de days thereafter until all such funds have been expended3 ,provided1 ,that such report shall include a detailed description of the use of such funds1 including categories and amounts1 the intended results and the results achieved1 a summary of other donor contributions1 and a description of the efforts undertaken by the ,secretary and ,administrator to increase other donor contributions for direct financial support3 ,provided further1 ,that such report shall also include the metrics established to measure such results4 7d7 ,funds made available for the purposes of subsection 7a7 shall be subject to the regular notification procedures of the ,committees on ,appropriations of the ,house of ,representatives and the ,senate4 ,,iv ,general ,provisions--,this ,act #adja4 ,each amount appropriated or made available by this ,act is in addition to amounts otherwise appropriated for the fiscal year involved4 #adjb4 ,no part of any appropriation contained in this ,act shall remain available for obligation beyond the current fiscal year unless expressly so provided herein4 #adjc4 ,unless otherwise provided for by this ,act1 the additional amounts appropriated by this ,act to appropriations accounts shall be available under the authorities and conditions applicable to such appropriations accounts for fiscal year #bjbc4 #adjd4 ,each amount provided by this division is designated by the ,congress as being for an emergency requirement pursuant to section #djja7;a77#a7 of ,s4 ,con4 ,res4 #ad 7#aagth ,congress71 the concurrent resolution on the budget for fiscal year #bjbb1 and section #a7;e7 of ,h4 ,res4 #aaea 7#aagth ,congress71 as engrossed in the ,house of ,representatives on ,june #h1 #bjbb4 ,this division may be cited as the ,ukraine ,supplemental ,appropriations ,act1 #bjbc4 ,c ,other ,matters ,i ,extensions1 ,technical ,corrections1 and ,other ,matters #aja4 ,extension of ,,fcc ,auction ,authority ,section #cji7;j77#aa7 of the ,communications ,act of #aicd 7#dg ,u4,s4,c4 #cji7;j77#aa77 is amended by striking ,september #cj1 #bjbb and inserting ,december #af1 #bjbb4 #ajb4 ,extension of ,authorization for ,special ,assessment for ,domestic ,trafficking ,victims' ,fund ,section #cjad7;a7 of title #ah1 ,united ,states ,code1 is amended1 in the matter preceding paragraph 7#a71 by striking ,september #cj1 #bjbb and inserting ,december #af1 #bjbb4 #ajc4 ,united ,states ,parole ,commission ,extension 7a7 ,short ,title ,this section may be cited as the ,united ,states ,parole ,commission ,extension ,act of #bjbb4 7b7 ,amendment of ,sentencing ,reform ,act of #aihd ,for purposes of section #bce7;b7 of the ,sentencing ,reform ,act of #aihd 7#ah ,u4,s4,c4 #ceea note2 ,public ,law #ih-dgc2 #ih ,stat4 #bjcb71 as such section relates to chapter #caa of title #ah1 ,united ,states ,code1 and the ,united ,states ,parole ,commission1 each reference in such section to #ce years or #ce-year period shall be deemed a reference to #ce years and #df days or #ce-year and #df-;day period1 respectively4 #ajd4 ,extension of ,commodity ,futures ,trading ,commission ,customer ,protection ,fund ,expenses ,account ,section #a7;b7 of ,public ,law #aag-be 7#ace ,stat4 #big7 is amended by striking ,october #a1 #bjbb each place it appears and inserting ,december #af1 #bjbb4 ,,ii ,budgetary ,effects #bja4 ,budgetary ,effects 7a7 ,statutory ,,paygo ,scorecards ,the budgetary effects of this division and each succeeding division shall not be entered on either ,,paygo scorecard maintained pursuant to section #d7;d7 of the ,statutory ,pay-,as-,you-,go ,act of #bjaj4 7b7 ,senate ,,paygo ,scorecards ,the budgetary effects of this division and each succeeding division shall not be entered on any ,,paygo scorecard maintained for purposes of section #dajf of ,h4 ,con4 ,res4 #ga 7#aaeth ,congress74 7c7 ,classification of ,budgetary ,effects ,notwithstanding ,rule #c of the ,budget ,scorekeeping ,guidelines set forth in the joint explanatory statement of the committee of conference accompanying ,conference ,report #aje-bag and section #bej7;c77#h7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe1 the budgetary effects of this division and each succeeding division shall not be estimated-- 7#a7 for purposes of section #bea of such ,act2 7#b7 for purposes of an allocation to the ,committee on ,appropriations pursuant to section #cjb7;a7 of the ,congressional ,budget ,act of #aigd2 and 7#c7 for purposes of paragraph 7#d77;,c7 of section #c of the ,statutory ,pay-,as-,you-,go ,act of #bjaj as being included in an appropriation ,act4 ,d ,health and ,human ,services ,extensions ,i ,medicare and ,medicaid #aja4 ,extension of increased inpatient hospital payment adjustment for certain low-volume hospitals 7a7 ,in general ,section #ahhf7;d77#ab7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#ab77 is amended-- 7#a7 in subparagraph 7,b71 in the matter preceding clause 7i71 by striking in fiscal year #bjbc and subsequent fiscal years and inserting during the portion of fiscal year #bjbc beginning on ,december #ag1 #bjbb1 and ending on ,september #cj1 #bjbc1 and in fiscal year #bjbd and subsequent fiscal years2 7#b7 in subparagraph 7,c77i7-- 7,a7 in the matter preceding subclause 7,i7-- 7i7 by inserting or portion of a fiscal year after for a fiscal year2 and 7ii7 by inserting and the portion of fiscal year #bjbc beginning on ,october #a1 #bjbb1 and ending on ,december #af1 #bjbb after through #bjbb2 7,b7 in subclause 7,,iii71 by inserting and the portion of fiscal year #bjbc beginning on ,october #a1 #bjbb1 and ending on ,december #af1 #bjbb after through #bjbb2 and 7,c7 in subclause 7,,iv71 by striking fiscal year #bjbc and inserting the portion of fiscal year #bjbc beginning on ,december #ag1 #bjbb1 and ending on ,september #cj1 #bjbc1 and fiscal year #bjbd2 and 7#c7 in subparagraph 7,d7-- 7,a7 in the matter preceding clause 7i71 by inserting or during the portion of fiscal year #bjbc beginning on ,october #a1 #bjbb1 and ending on ,december #af1 #bjbb after through #bjbb2 and 7,b7 in clause 7ii71 by inserting and the portion of fiscal year #bjbc beginning on ,october #a1 #bjbb1 and ending on ,december #af1 #bjbb after through #bjbb4 7b7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the provisions of1 including the amendments made by1 this section by program instruction or otherwise4 #ajb4 ,extension of the ,medicare-dependent hospital 7,,mdh7 program 7a7 ,in general ,section #ahhf7;d77#e77;,g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77;,g77 is amended-- 7#a7 in clause 7i71 by striking ,october #a1 #bjbb and inserting ,december #ag1 #bjbb2 and 7#b7 in clause 7ii77,,ii71 by striking ,october #a1 #bjbb and inserting ,december #ag1 #bjbb4 7b7 ,conforming amendments 7#a7 ,extension of target amount ,section #ahhf7;b77#c77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,d77 is amended-- 7,a7 in the matter preceding clause 7i71 by striking ,october #a1 #bjbb and inserting ,december #ag1 #bjbb2 and 7,b7 in clause 7iv71 by inserting and the portion of fiscal year #bjbc beginning on ,october #a1 #bjbb1 and ending on ,december #af1 #bjbb1 after through fiscal year #bjbb4 7#b7 ,permitting hospitals to decline reclassification ,section #aceja7;e77#b7 of the ,omnibus ,budget ,reconciliation ,act of #aiic 7#db ,u4,s4,c4 #acieww note7 is amended by striking or fiscal year #bjjj through fiscal year #bjbb1 and inserting fiscal year #bjjj through fiscal year #bjbb1 or the portion of fiscal year #bjbc beginning on ,october #a1 #bjbb1 and ending on ,december #af1 #bjbb4 #ajc4 ,extension of increased ,f,m,a,ps for the territories ,section #aije7;ff7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7ff77 is amended by striking ,december #ac each place it appears and inserting ,december #af in each such place4 #ajd4 ,reduction of ,medicare ,improvement ,fund ,section #ahih7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a77 is amended by striking #g1ejj1jjj1jjj and inserting #g1cjh1jjj1jjj4 ,,ii ,human ,services #bja4 ,extension of maternal1 infant1 and early childhood home visiting programs ,activities authorized by section #eaa of the ,social ,security ,act shall continue through ,december #af1 #bjbb1 in the manner authorized for fiscal year #bjbb1 and out of any money in the ,treasury of the ,united ,states not otherwise appropriated1 there is hereby appropriated for such purpose an amount equal to the pro rata portion of the amount appropriated for such activities for fiscal year #bjbb4 #bjb4 ,extension of child and family services programs ,activities authorized by part ,b of title ,,iv of the ,social ,security ,act shall continue through ,december #af1 #bjbb1 in the manner authorized for fiscal year #bjbb1 and out of any money in the ,treasury of the ,united ,states not otherwise appropriated1 there are hereby appropriated such sums as may be necessary for such purpose4 ,,iii ,public ,health #cja4 ,extension of the program to deem certain health professional volunteers employees of the ,public ,health ,service under certain circumstances 7a7 ,in general ,section #bbd7q7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bcc7q77 is amended by striking paragraph 7#f74 7b7 ,technical corrections ,section #bbd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bcc7 is amended-- 7#a7 in subsection 7g77#a77;,h77iv71 by striking this section4 and inserting this section742 7#b7 in subsection 7k77#c71 by inserting governing board members1 after officers12 7#c7 in subsection 7p77#g77;,a77i71 by moving the margin of subclause 7,,ii7 #b ems to the left2 and 7#d7 in subsection 7q77#e77;,a71 by striking and paragraph 7#f74 #cjb4 ,extension of authorization for a commissioned officer of the ,public ,health ,service ,to accumulate excess annual leave ,for purposes of annual leave accumulated in fiscal year #bjbb1 the authority provided in section #bajf of division ,c of ,public ,law #aaf-aei 7#db ,u4,s4,c4 #baj-a note7 shall apply to such leave by substituting #bjbb for #bjbj in subsections 7a7 and 7d77#b74 ,,iv ,indian ,health #dja4 ,extension of moratorium ,section #dbd7;a7 of title ,,iv of division ,g of ,public ,law #aac-gf is amended by striking ,october #a1 #bjai and inserting ,december #af1 #bjbb4 ,e ,veterans ,affairs ,extensions ,i ,extensions of authorities relating to health care #aja4 ,extension of authority for collection of copayments for hospital care and nursing home care ,section #agaj7;f77#b77;,b7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbd4 #ajb4 ,extension of requirement to provide nursing home care to certain veterans with service-connected disabilities ,section #agaj;,a7d7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbd4 #ajc4 ,extension of authority to continue ,,dod-,,va ,health ,care ,sharing ,incentive ,fund ,section #haaa7;d77#c7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbc and inserting ,september #cj1 #bjbf4 #ajd4 ,extension of authority for joint ,department of ,defense-,department of ,veterans ,affairs medical facility demonstration fund ,section #agjd7;e7 of the ,national ,defense ,authorization ,act for ,fiscal ,year #bjaj 7,public ,law #aaa-hd2 #abc ,stat4 #begc71 as most recently amended by section #gae of the ,national ,defense ,authorization ,act for ,fiscal ,year #bjbb 7,public ,law #aag-ha2 #ace ,stat4 #aghg71 is amended by striking ,september #cj1 #bjbc and inserting ,september #cj1 #bjbd4 #aje4 ,extension of temporary expansion of payments and allowances for beneficiary travel in connection with veterans receiving care from ,vet ,centers ,section #ajd7;a7 of the ,honoring ,america's ,veterans and ,caring for ,camp ,lejeune ,families ,act of #bjab 7,public ,law #aab-aed2 #abf ,stat4 #aafi71 as most recently amended by section #c of the ,department of ,veterans ,affairs ,expiring ,authorities ,act of #bjba 7,public ,law #aag-db2 #ace ,stat4 #cdb71 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbc4 ,,ii ,extensions of authorities relating to benefits #bja4 ,extension of authority to transport individuals to and from ,department of ,veterans ,affairs facilities ,section #aaa;,a7a77#b7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbd4 #bjb4 ,extension of authority to maintain regional office in the ,republic of the ,philippines ,section #cae7;b7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbd4 #bjc4 ,extension of authority for report on equitable relief provided due to administrative error ,section #ejc7;c7 of title #ch1 ,united ,states ,code1 is amended by striking ,december #ca1 #bjbb and inserting ,december #ca1 #bjbd4 #bjd4 ,extension of authority to provide assistance for specially adapted housing for disabled veterans residing temporarily in housing owned by a family member ,section #bajb;,a7e7 of title #ch1 ,united ,states ,code1 is amended by striking ,december #ca1 #bjbb and inserting ,december #ca1 #bjbd4 #bje4 ,extension of specially adapted housing assistive technology grant program ,section #bajh7;g7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbd4 ,,iii ,extensions of authorities relating to homeless veterans #cja4 ,extension of authorization of appropriations for homeless veterans reintegration programs ,section #bjba7;e77#a77;,f7 of title #ch1 ,united ,states ,code1 is amended by striking #bjbb and inserting #bjbd4 #cjb4 ,extension of authorization of appropriations for homeless women veterans and homeless veterans with children reintegration grant program ,section #bjba;,a7f77#a7 of title #ch1 ,united ,states ,code1 is amended by striking #bjbb and inserting #bjbd4 #cjc4 ,extension of authority for treatment and rehabilitation for seriously mentally ill and homeless veterans 7a7 ,general treatment ,section #bjca7;b7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbd4 7b7 ,additional services at certain locations ,section #bjcc7;d7 of such title is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbd4 #cjd4 ,extension of funding for financial assistance for supportive services for very low-income veteran families in permanent housing ,section #bjdd7;e77#a77;,h7 of title #ch1 ,united ,states ,code1 is amended by striking and #bjbb and inserting through #bjbd4 #cje4 ,extension of funding for grant program for homeless veterans with special needs ,section #bjfa7;d77#a7 of title #ch1 ,united ,states ,code1 is amended by striking #bjbb and inserting #bjbd4 #cjf4 ,extension of authority for the ,advisory ,committee on ,homeless ,veterans ,section #bjff7;d7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbf4 ,,iv ,extensions of other authorities #dja4 ,extension of authorization of appropriations for monthly assistance allowance under the ,office of ,national ,veterans ,sports ,programs and ,special ,events ,section #cbb7;d77#d7 of title #ch1 ,united ,states ,code1 is amended by striking #bjbb and inserting #bjbf4 #djb4 ,extension and authorization of appropriations for adaptive sports programs for disabled veterans and members of the ,armed ,forces 7a7 ,authorization of appropriations ,subsection 7g77#a77;,b7 of section #eba;,a of title #ch1 ,united ,states ,code1 is amended by striking and #bjbb and inserting through #bjbf4 7b7 ,extension ,subsection 7l7 of such section is amended by striking #bjbb and inserting #bjbf4 7c7 ,technical correction ,subsection 7g77#a77;,a7 of such section is amended by striking 4 for each of fiscal years #bjaj through #bjbj4 #djc4 ,extension of ,advisory ,committee on ,minority ,veterans ,section #edd7;e7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbf4 #djd4 ,extension of ,veterans' ,advisory ,committee on ,education ,section #cfib7;c7 of title #ch1 ,united ,states ,code1 is amended by striking ,december #ca1 #bjbb and inserting ,december #ca1 #bjbf4 #dje4 ,extension of authority for transfer of real property ,section #haah7;a77#e7 of title #ch1 ,united ,states ,code1 is amended by striking ,september #cj1 #bjbb and inserting ,september #cj1 #bjbd4 ,f ,,fda ,user ,fee ,reauthorization ,act of #bjbb #a4 ,short title ,this division may be cited as the ,,fda ,user ,fee ,reauthorization ,act of #bjbb4 #b4 ,table of contents ,the table of contents for this division is as follows3 ,,division ,f--,,fda ,user ,fee ,reauthorization ,act of #bjbb,sec4 #a4 ,short title4,sec4 #b4 ,table of contents4,,title ,i--,fees ,relating to ,drugs,sec4 #ajja4 ,short title2 finding4,sec4 #ajjb4 ,definitions4,sec4 #ajjc4 ,authority to assess and use drug fees4,sec4 #ajjd4 ,reauthorization2 reporting requirements4,sec4 #ajje4 ,sunset dates4,sec4 #ajjf4 ,effective date4,sec4 #ajjg4 ,savings clause4,,title ,,ii--,fees ,relating to ,devices,sec4 #bjja4 ,short title2 finding4,sec4 #bjjb4 ,definitions4,sec4 #bjjc4 ,authority to assess and use device fees4,sec4 #bjjd4 ,reauthorization2 reporting requirements4,sec4 #bjje4 ,conformity assessment pilot program4,sec4 #bjjf4 ,reauthorization of third-party review program4,sec4 #bjjg4 ,sunset dates4,sec4 #bjjh4 ,effective date4,sec4 #bjji4 ,savings clause4,,title ,,iii--,fees ,relating to ,generic ,drugs,sec4 #cjja4 ,short title2 finding4,sec4 #cjjb4 ,authority to assess and use human generic drug fees4,sec4 #cjjc4 ,reauthorization2 reporting requirements4,sec4 #cjjd4 ,sunset dates4,sec4 #cjje4 ,effective date4,sec4 #cjjf4 ,savings clause4,,title ,,iv--,fees ,relating to ,biosimilar ,biological ,products,sec4 #djja4 ,short title2 finding4,sec4 #djjb4 ,definitions4,sec4 #djjc4 ,authority to assess and use biosimilar biological product fees4,sec4 #djjd4 ,reauthorization2 reporting requirements4,sec4 #djje4 ,sunset dates4,sec4 #djjf4 ,effective date4,sec4 #djjg4 ,savings clause4,,title ,v--,reauthorization of other provisions,sec4 #ejja4 ,reauthorization of the best pharmaceuticals for children program4,sec4 #ejjb4 ,reauthorization of the humanitarian device exemption incentive4,sec4 #ejjc4 ,reauthorization of the pediatric device consortia program4,sec4 #ejjd4 ,reauthorization of provision pertaining to drugs containing single enantiomers4,sec4 #ejje4 ,reauthorization of the critical path public-private partnership4,sec4 #ejjf4 ,reauthorization of orphan drug grants4,sec4 #ejjg4 ,reauthorization of certain device inspections4,sec4 #ejjh4 ,reauthorization of reporting requirements related to pending generic drug applications and priority review applications4 ,i ,fees ,relating to ,drugs #ajja4 ,short title2 finding 7a7 ,short ,title ,this title may be cited as the ,prescription ,drug ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized by the amendments made by this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications1 including postmarket drug safety activities1 as set forth in the goals identified for purposes of part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #ajjb4 ,definitions 7a7 ,human drug application ,section #gce7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#a77 is amended1 in the matter following subparagraph 7,b71 by striking an allergenic extract product1 or and inserting does not include an application with respect to an allergenic extract product licensed before ,october #a1 #bjbb1 does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the ,secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before ,october #a1 #bjbb1 does not include an application with respect to4 7b7 ,prescription drug product ,section #gce7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#c77 is amended-- 7#a7 by redesignating subparagraphs 7,a71 7,b71 and 7,c7 as clauses 7i71 7ii71 and 7iii71 respectively2 7#b7 by striking 7#c7 ,the term and inserting 7#c77;,a7 ,the term2 7#c7 by striking ,such term does not include whole blood and inserting the following3 7,b7 ,such term does not include whole blood 2 7#d7 by striking an allergenic extract product1 and inserting an allergenic extract product licensed before ,october #a1 #bjbb1 a standardized allergenic extract product submitted pursuant to a notification to the applicant from the ,secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before ,october #a1 #bjbb12 and 7#e7 by adding at the end the following3 7,c7 7i7 ,if a written request to place a product in the discontinued section of either of the lists referenced in subparagraph 7,a77iii7 is submitted to the ,secretary on behalf of an applicant1 and the request identifies the date the product is1 or will be1 withdrawn from sale1 then for purposes of assessing the prescription drug program fee under section #gcf7;a77#b71 the ,secretary shall consider such product to have been included in the discontinued section on the later of-- 7,i7 the date such request was received2 or 7,,ii7 if the product will be withdrawn from sale on a future date1 such future date when the product is withdrawn from sale4 7ii7 ,for purposes of this subparagraph1 a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product1 whether or not the applicant has ordered recall of all previously distributed lots of the product1 except that a routine1 temporary interruption in supply shall not render a product withdrawn from sale4 4 7c7 ,skin-,test diagnostic product ,section #gce of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is amended by adding at the end the following3 7#ab7 ,the term skin-test diagnostic product-- 7,a7 means a product-- 7i7 for prick1 scratch1 intradermal1 or subcutaneous administration2 7ii7 expected to produce a limited1 local reaction at the site of administration 7if positive71 rather than a systemic effect2 7iii7 not intended to be a preventive or therapeutic intervention2 and 7iv7 intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of-- 7,i7 an allergy to an antimicrobial agent2 7,,ii7 an allergy that is not to an antimicrobial agent1 if the diagnostic product was authorized for marketing prior to ,october #a1 #bjbb2 or 7,,iii7 infection with fungal or mycobacterial pathogens2 and 7,b7 includes positive and negative controls required to interpret the results of a product described in subparagraph 7,a74 4 #ajjc4 ,authority to assess and use drug fees 7a7 ,types of fees 7#a7 ,human drug application fee ,section #gcf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is amended-- 7,a7 in the matter preceding paragraph 7#a71 by striking fiscal year #bjah and inserting fiscal year #bjbc2 7,b7 in paragraph 7#a77;,a71 by striking 7c77#e7 each place it appears and inserting 7c77#f72 7,c7 in paragraph 7#a77;,c71 by inserting prior to approval after or was withdrawn2 and 7,d7 in paragraph 7#a71 by adding at the end the following3 7,h7 ,exception for skin-test diagnostic products ,a human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph 7,a74 4 7#b7 ,prescription drug program fee ,section #gcf7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77#b77 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 by striking ,except as provided in subparagraphs 7,b7 and 7,c7 and inserting the following3 7i7 ,payment of fees ,except as provided in subparagraphs 7,b7 and 7,c7 2 7ii7 by striking subsection 7c77#e7 and inserting subsection 7c77#f72 and 7iii7 by adding at the end the following3 7ii7 ,special rule for previously discontinued drug products ,if a drug product that is identified in a human drug application approved as of ,october #a of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section #gce7c77;,a77iii71 and on any subsequent day during such fiscal year the drug product is a prescription drug product1 then except as provided in subparagraphs 7,b7 and 7,c71 each person who is named as the applicant in a human drug application with respect to such product1 and who1 after ,september #a1 #aiib1 had pending before the ,secretary a human drug application or supplement1 shall pay the annual prescription drug program fee established for a fiscal year under subsection 7c77#f7 for such prescription drug product4 ,such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable4 2 and 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,exception for certain prescription drug products ,a prescription drug program fee shall not be assessed for a prescription drug product under subparagraph 7,a7 if such product is-- 7i7 a large volume parenteral product 7a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to #ajj m,l1 not including powders for reconstitution or pharmacy bulk packages7 identified on the list compiled under section #eje7;j77#g72 7ii7 pharmaceutically equivalent 7as defined in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulation77 to another product on the list of products compiled under section #eje7;j77#g7 7not including the discontinued section of such list72 or 7iii7 a skin-test diagnostic product4 4 7b7 ,fee revenue amounts 7#a7 ,in general ,paragraph 7#a7 of section #gcf7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is amended to read as follows3 7#a7 ,in general ,for each of the fiscal years #bjbc through #bjbg1 fees under subsection 7a7 shall1 except as provided in subsections 7c71 7d71 7f71 and 7g71 be established to generate a total revenue amount under such subsection that is equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year 7as determined under subsection 7c77#b772 7,d7 the dollar amount equal to the capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#c772 7,e7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#d772 7,f7 the dollar amount equal to the additional direct cost adjustment for the fiscal year 7as determined under subsection 7c77#e772 and 7,g7 additional dollar amounts for each fiscal year as follows3 7i7 #fe1ggc1fic for fiscal year #bjbc4 7ii7 #be1jig1fga for fiscal year #bjbd4 7iii7 #ad1aed1afi for fiscal year #bjbe4 7iv7 #d1hfd1hfj for fiscal year #bjbf4 7v7 #a1cad1fbj for fiscal year #bjbg4 4 7#b7 ,annual base revenue ,paragraph 7#c7 of section #gcf7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is amended to read as follows3 7#c7 ,annual base revenue ,for purposes of paragraph 7#a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjbc1 #a1aea1ebb1ieh2 and 7,b7 for fiscal years #bjbd through #bjbg1 the dollar amount of the total revenue amount established under paragraph 7#a7 for the previous fiscal year1 not including any adjustments made under subsection 7c77#d7 or 7c77#e74 4 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment ,section #gcf7;c77#a77;,b77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77#a77;,b77ii77 is amended by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv4 7#b7 ,strategic hiring and retention adjustment ,section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended-- 7,a7 by redesignating paragraphs 7#b7 through 7#f7 as paragraphs 7#c7 through 7#g71 respectively2 and 7,b7 by inserting after paragraph 7#a7 the following3 7#b7 ,strategic hiring and retention adjustment ,for each fiscal year1 after the annual base revenue established in subsection 7b77#a77;,a7 is adjusted for inflation in accordance with paragraph 7#a71 the ,secretary shall further increase the fee revenue and fees by the following amounts3 7,a7 ,for fiscal year #bjbc1 #i1jjj1jjj4 7,b7 ,for each of fiscal years #bjbd through #bjbg1 #d1jjj1jjj4 4 7#c7 ,capacity planning adjustment ,paragraph 7#c71 as redesignated1 of section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended to read as follows3 7#c7 ,capacity planning adjustment 7,a7 ,in general ,for each fiscal year1 after the annual base revenue established in subsection 7b77#a77;,a7 is adjusted in accordance with paragraphs 7#a7 and 7#b71 such revenue shall be adjusted further for such fiscal year1 in accordance with this paragraph1 to reflect changes in the resource capacity needs of the ,secretary for the process for the review of human drug applications4 7,b7 ,methodology ,for purposes of this paragraph1 the ,secretary shall employ the capacity planning methodology utilized by the ,secretary in setting fees for fiscal year #bjba1 as described in the notice titled ,prescription ,drug ,user ,fee ,rates for ,fiscal ,year #bjba published in the ,federal ,register on ,august #c1 #bjbj 7#he ,fed4 ,reg4 #dffea74 ,the workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and1 as feasible1 additional activities that are directly related to the direct review of applications and supplements1 including additional formal meeting types1 the direct review of postmarketing commitments and requirements1 the direct review of risk evaluation and mitigation strategies1 and the direct review of annual reports for approved prescription drug products4 ,subject to the exceptions in the preceding sentence1 the ,secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities1 including those activities that the ,secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year #bjba4 7,c7 ,limitation ,under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections 7b77#a77;,a7 7the annual base revenue for the fiscal year71 7b77#a77;,b7 7the dollar amount of the inflation adjustment for the fiscal year71 and 7b77#a77;,c7 7the dollar amount of the strategic hiring and retention adjustment for the fiscal year74 7,d7 ,publication in ,federal ,register ,the ,secretary shall publish in the ,federal ,register notice under paragraph 7#f7 of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph4 4 7#d7 ,operating reserve adjustment ,paragraph 7#d71 as redesignated1 of section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended-- 7,a7 by amending subparagraph 7,a7 to read as follows3 7,a7 ,increase ,for fiscal year #bjbc and subsequent fiscal years1 the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts3 7i7 ,for fiscal year #bjbc1 at least #h weeks of operating reserves4 7ii7 ,for fiscal year #bjbd1 at least #i weeks of operating reserves4 7iii7 ,for fiscal year #bjbe and subsequent fiscal years1 at least #aj weeks of operating reserves4 2 and 7,b7 in subparagraph 7,c71 by striking paragraph 7#e7 and inserting paragraph 7#f74 7#e7 ,additional direct cost adjustment ,paragraph 7#e71 as redesignated1 of section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended to read as follows3 7#e7 ,additional direct cost adjustment 7,a7 ,increase ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 7#c71 and 7#d71 further increase the fee revenue and fees-- 7i7 for fiscal year #bjbc1 by #dd1chf1aej2 and 7ii7 for each of fiscal years #bjbd through #bjbg1 by the amount set forth in clauses 7i7 through 7iv7 of subparagraph 7,b71 as applicable1 multiplied by the ,consumer ,price ,index for urban consumers 7,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 ,not ,seasonally ,adjusted2 ,all ,items2 ,annual ,index7 for the most recent year of available data1 divided by such ,index for #bjba4 7,b7 ,applicable amounts ,the amounts referred to in subparagraph 7,a77ii7 are the following3 7i7 ,for fiscal year #bjbd1 #fj1ifg1iic4 7ii7 ,for fiscal year #bjbe1 #ce1gii1cad4 7iii7 ,for fiscal year #bjbf1 #ce1gii1 #cad4 7iv7 ,for fiscal year #bjbg1 #ce1gii1cad4 4 7#f7 ,annual fee setting ,paragraph 7#f71 as redesignated1 of section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended by striking ,september #cj1 #bjag and inserting ,september #cj1 #bjbb4 7d7 ,crediting and availability of fees ,section #gcf7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#c77 is amended by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg4 7e7 ,written requests for waivers1 reductions1 exemptions1 and returns2 disputes concerning fees ,section #gcf7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7i77 is amended to read as follows3 7i7 ,written requests for waivers1 reductions1 exemptions1 and returns2 disputes concerning fees ,to qualify for consideration for a waiver or reduction under subsection 7d71 an exemption under subsection 7k71 or the return of any fee paid under this section1 including if the fee is claimed to have been paid in error1 a person shall-- 7#a7 not later than #ahj days after such fee is due1 submit to the ,secretary a written request justifying such waiver1 reduction1 exemption1 or return2 and 7#b7 include in the request any legal authorities under which the request is made4 4 7f7 ,orphan drugs ,section #gcf7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is amended-- 7#a7 in paragraph 7#a77;,b71 by striking during the previous year and inserting as determined under paragraph 7#b72 and 7#b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,evidence of qualification ,an exemption under paragraph 7#a7 applies with respect to a drug only if the applicant involved submits a certification that the applicant's gross annual revenues did not exceed #ej1jjj1jjj for the last calendar year ending prior to the fiscal year for which the exemption is requested4 ,such certification shall be supported by-- 7,a7 tax returns submitted to the ,united ,states ,internal ,revenue ,service2 or 7,b7 as necessary1 other appropriate financial information4 4 #ajjd4 ,reauthorization2 reporting requirements ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is amended-- 7#a7 in subsection 7a77#a71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 7#b7 by striking ,prescription ,drug ,user ,fee ,amendments of #bjag each place it appears and inserting ,prescription ,drug ,user ,fee ,amendments of #bjbb2 7#c7 in subsection 7a77#c77;,a71 by striking ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter and inserting ,not later than #cj calendar days after the end of each quarter of each fiscal year for which fees are collected under this part2 7#d7 in subsection 7a77#d71 by striking ,beginning with fiscal year #bjbj1 the and inserting ,the2 7#e7 in subsection 7b71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 7#f7 in subsection 7c71 by striking ,beginning with fiscal year #bjah1 for and inserting ,for2 and 7#g7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking fiscal year #bjbb and inserting fiscal year #bjbg2 and 7,b7 in paragraph 7#e71 by striking ,january #ae1 #bjbb and inserting ,january #ae1 #bjbg4 #ajje4 ,sunset dates 7a7 ,authorization ,sections #gce and #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting ,requirements ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous ,sunset ,provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #ajd of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #ajjf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq47 shall be assessed for all human drug applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #ajjg4 ,savings clause ,notwithstanding the amendments made by this title1 part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to human drug applications and supplements 7as defined in such part as of such day7 that were accepted by the ,food and ,drug ,administration for filing on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,ii ,fees ,relating to ,devices #bjja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,medical ,device ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices1 as set forth in the goals identified for purposes of part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #bjjb4 ,definitions ,section #gcg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is amended-- 7#a7 in paragraph 7#i7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking and premarket notification submissions and inserting premarket notification submissions1 and de novo classification requests2 7,b7 in subparagraph 7,d71 by striking and submissions and inserting submissions1 and de novo classification requests2 7,c7 in subparagraph 7,f71 by striking and premarket notification submissions and inserting premarket notification submissions1 and de novo classification requests2 7,d7 in each of subparagraphs 7,g7 and 7,h71 by striking or submissions and inserting submissions1 or requests2 and 7,e7 in subparagraph 7,k71 by striking or premarket notification submissions and inserting premarket notification submissions1 or de novo classification requests2 and 7#b7 in paragraph 7#aa71 by striking #bjaf and inserting #bjba4 #bjjc4 ,authority to assess and use device fees 7a7 ,types of ,fees ,section #gch7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77 is amended-- 7#a7 in paragraph 7#a71 by striking fiscal year #bjah and inserting fiscal year #bjbc2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking ,october #a1 #bjag and inserting ,october #a1 #bjbb2 7ii7 in clause 7iii71 by striking #ge percent and inserting #hj percent2 and 7iii7 in clause 7viii71 by striking #c4d percent and inserting #d4e percent2 7,b7 in subparagraph 7,b77iii71 by striking or premarket notification submission and inserting premarket notification submission1 or de novo classification request2 and 7,c7 in subparagraph 7,c71 by striking or periodic reporting concerning a class ,,iii device and inserting periodic reporting concerning a class ,,iii device1 or de novo classification request4 7b7 ,fee ,amounts ,section #gch7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,base fee amounts specified ,for purposes of paragraph 7#a71 the base fee amounts specified in this paragraph are as follows3 ,fee ,type,fiscal ,year #bjbc;,fiscal ,year #bjbd;,fiscal ,year #bjbe;,fiscal ,year #bjbf;,fiscal ,year #bjbg,premarket ,application#dbe1jjjdce1jjjdde1jjjdee1jj jdgj1jjj;,establishment ,registration#f1bejf1hgeg1ajjg1egeh1dfe 2 and 7#c7 by amending paragraph 7#c7 to read as follows3 7#c7 ,total revenue amounts specified ,for purposes of paragraph 7#a71 the total revenue amounts specified in this paragraph are as follows3 7,a7 #cab1fjf1jjj for fiscal year #bjbc4 7,b7 #cce1gej1jjj for fiscal year #bjbd4 7,c7 #cej1gdf1djj for fiscal year #bjbe4 7,d7 #cff1dhf1cjj for fiscal year #bjbf4 7,e7 #dah1cdc1jjj for fiscal year #bjbg4 4 7c7 ,annual ,fee ,setting2 ,adjustments ,section #gch7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7c77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjag and inserting #bjbb2 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by striking #bjah and inserting #bjbc2 7,b7 in subparagraph 7,b7-- 7i7 in the matter preceding clause 7i71 by striking fiscal year #bjah and inserting fiscal year #bjbc2 and 7ii7 in clause 7ii71 by striking fiscal year #bjaf and inserting fiscal year #bjbb2 7,c7 in subparagraph 7,c71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 and 7,d7 in subparagraph 7,d71 in the matter preceding clause 7i71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg2 7#c7 in paragraph 7#c71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#d7 by redesignating paragraphs 7#d7 and 7#e7 as paragraphs 7#g7 and 7#h71 respectively2 and 7#e7 by inserting after paragraph 7#c7 the following3 7#d7 ,performance improvement adjustment 7,a7 ,in general ,for each of fiscal years #bjbe through #bjbg1 after the adjustments under paragraphs 7#b7 and 7#c71 the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the ,secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section #bjja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb1 as the ,secretary determines necessary to achieve an increase in total fee collections for such fiscal year equal to the following amounts1 as applicable3 7i7 ,for fiscal year #bjbe1 the product of-- 7,i7 the amount determined under subparagraph 7,b77i77,i72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7ii7 ,for fiscal year #bjbf1 the product of-- 7,i7 the sum of the amounts determined under subparagraphs 7,b77i77,,ii71 7,b77ii77,i71 and 7,b77iii77,i72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7iii7 ,for fiscal year #bjbg1 the product of-- 7,i7 the sum of the amounts determined under subparagraphs 7,b77i77,,iii71 7,b77ii77,,ii71 and 7,b77iii77,,ii72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7,b7 ,amounts 7i7 ,presubmission amount ,for purposes of subparagraph 7,a71 with respect to the ,presubmission ,written ,feedback goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbe1 #ae1cif1fjj if such goal for fiscal year #bjbc is met4 7,,ii7 ,for fiscal year #bjbf3 7aa7 #ae1cif1fjj if such goal for fiscal year #bjbc is met and such goal for fiscal year #bjbd is not met4 7bb7 #cf1gib1bjj if such goal for fiscal year #bjbd is met4 7,,iii7 ,for fiscal year #bjbg3 7aa7 #ae1cif1fjj if such goal for fiscal year #bjbc is met and such goal for each of fiscal years #bjbd and #bjbe is not met4 7bb7 #cf1gib1bjj if such goal for fiscal year #bjbd is met and such goal for fiscal year #bjbe is not met4 7cc7 #dj1egb1fjj if such goal for fiscal year #bjbe is met4 7ii7 ,de novo classification request amount ,for purposes of subparagraph 7,a71 with respect to the ,de ,novo ,decision goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbf1 #f1cbc1ejj if such goal for fiscal year #bjbc is met4 7,,ii7 ,for fiscal year #bjbg3 7aa7 #f1cbc1ejj if such goal for fiscal year #bjbc is met and such goal for fiscal year #bjbd is not met4 7bb7 #aa1gfe1djj if such goal for fiscal year #bjbd is met4 7iii7 ,premarket notification and premarket approval amount ,for purposes of subparagraph 7,a71 with respect to the #eaj7k7 decision goal1 #eaj7k7 ,shared ,outcome ,total ,time to ,decision goal1 ,,pma decision goal1 and ,,pma ,shared ,outcome ,total ,time to ,decision goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbf1 #a1jbj1jjj if the #d goals for fiscal year #bjbc are met4 7,,ii7 ,for fiscal year #bjbg3 7aa7 #a1jbj1jjj if the #d goals for fiscal year #bjbc are met and one or more of the #d goals for fiscal year #bjbd are not met4 7bb7 #c1ijf1jjj if the #d goals for fiscal year #bjbd are met4 7,c7 ,performance calculation ,for purposes of this paragraph1 performance of the following goals shall be determined as specified in the letters described in section #bjja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb and based on data available1 as follows3 7i7 ,the performance of the ,presubmission ,written ,feedback goal shall be based on data available as of-- 7,i7 for fiscal year #bjbc1 ,march #ca1 #bjbd2 7,,ii7 for fiscal year #bjbd1 ,march #ca1 #bjbe2 and 7,,iii7 for fiscal year #bjbe1 ,march #ca1 #bjbf4 7ii7 ,the performance of the ,de ,novo ,decision goal1 #eaj7k7 decision goal1 #eaj7k7 ,shared ,outcome ,total ,time to ,decision goal1 ,,pma decision goal1 and ,,pma ,shared ,outcome ,total ,time to ,decision goal shall be based on data available as of-- 7,i7 for fiscal year #bjbc1 ,march #ca1 #bjbe2 and 7,,ii7 for fiscal year #bjbd1 ,march #ca1 #bjbf4 7,d7 ,goals defined ,for purposes of this paragraph1 the terms ,presubmission ,written ,feedback goal1 ,de ,novo ,decision goal1 #eaj7k7 decision goal1 #eaj7k7 ,shared ,outcome ,total ,time to ,decision goal1 ,,pma decision goal1 and ,,pma ,shared ,outcome ,total ,time to ,decision goal refer to the goals identified by the same names in the letters described in section #bjja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb4 7#e7 ,hiring adjustment 7,a7 ,in general ,for each of fiscal years #bjbe through #bjbg1 after the adjustments under paragraphs 7#b71 7#c71 and 7#d71 if applicable1 if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph 7,b7 for the applicable fiscal years1 the base establishment registration fee amounts shall be decreased as the ,secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph 7,c74 7,b7 ,thresholds ,the thresholds specified in this subparagraph are as follows3 7i7 ,for fiscal year #bjbe1 the threshold is #abc hires for fiscal year #bjbc4 7ii7 ,for fiscal year #bjbf1 the threshold is #ch hires for fiscal year #bjbd4 7iii7 ,for fiscal year #bjbg1 the threshold is-- 7,i7 #bb hires for fiscal year #bjbe if the base establishment registration fees are not increased by the amount determined under paragraph 7#d77;,a77i72 or 7,,ii7 #ge hires for fiscal year #bjbe if such fees are so increased4 7,c7 ,hiring adjustment amount ,the hiring adjustment amount for fiscal year #bjbe and each subsequent fiscal year is the product of-- 7i7 the number of hires by which the hiring goal specified in subparagraph 7,d7 for the fiscal year before the prior fiscal year was not met2 7ii7 #gb1hgg2 and 7iii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for the fiscal year for which the hiring goal was not met4 7,d7 ,hiring goals ,the hiring goals for each of fiscal years #bjbc through #bjbe are as follows3 7i7 ,for fiscal year #bjbc1 #add hires4 7ii7 ,for fiscal year #bjbd1 #db hires4 7iii7 ,for fiscal year #bjbe3 7,i7 #bd hires if the base establishment registration fees are not increased by the amount determined under paragraph 7#d77;,a77i74 7,,ii7 #hc hires if the base establishment registration fees are increased by the amount determined under paragraph 7#d77;,a77i74 7,e7 ,number of hires ,for purposes of this paragraph1 the number of hires for a fiscal year shall be determined by the ,secretary as set forth in the letters described in section #bjja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb4 7#f7 ,operating reserve adjustment 7,a7 ,in general ,for each of fiscal years #bjbc through #bjbg1 after the adjustments under paragraphs 7#b71 7#c71 7#d71 and 7#e71 if applicable1 if the ,secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph 7,b71 the ,secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves4 7,b7 ,designated amount ,subject to subparagraph 7,c71 for each fiscal year1 the designated amount in this subparagraph is equal to the sum of-- 7i7 #ac weeks of operating reserves of carryover user fees2 and 7ii7 #a month of operating reserves maintained pursuant to paragraph 7#h74 7,c7 ,excluded amount ,for the period of fiscal years #bjbc through #bjbf1 a total amount equal to #aah1jjj1jjj shall not be considered part of the designated amount under subparagraph 7,b7 and shall not be subject to the decrease under subparagraph 7,a74 4 7d7 ,conditions ,section #gch7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77 is amended-- 7#a7 in paragraph 7#a77;,a71 by striking #cbj1hbe1jjj and inserting #cih1eff1jjj2 and 7#b7 in paragraph 7#b71 by inserting de novo classification requests1 after class ,,iii device14 7e7 ,crediting and ,availability of ,fees ,section #gch7;h77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77#c77 is amended to read as follows3 7#c7 ,authorization of appropriations 7,a7 ,in general ,for each of fiscal years #bjbc through #bjbg1 there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph 7,b71 less the amount of reductions determined under subparagraph 7,c74 7,b7 ,revenue amount ,for purposes of this paragraph1 the revenue amount for each fiscal year is the sum of-- 7i7 the total revenue amount under subsection 7b77#c7 for the fiscal year1 as adjusted under paragraphs 7#b7 and 7#c7 of subsection 7c72 and 7ii7 the performance improvement adjustment amount for the fiscal year under subsection 7c77#d71 if applicable4 7,c7 ,amount of reductions ,for purposes of this paragraph1 the amount of reductions for each fiscal year is the sum of-- 7i7 the hiring adjustment amount for the fiscal year under subsection 7c77#e71 if applicable2 and 7ii7 the operating reserve adjustment amount for the fiscal year under subsection 7c77#f71 if applicable4 4 #bjjd4 ,reauthorization2 reporting requirements 7a7 ,performance reports ,section #gch;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is amended-- 7#a7 by striking fiscal year #bjah each place it appears and inserting fiscal year #bjbc2 7#b7 by striking ,medical ,device ,user ,fee ,amendments of #bjag each place it appears and inserting ,medical ,device ,user ,fee ,amendments of #bjbb2 7#c7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 by redesignating the second clause 7iv7 7relating to analysis7 as clause 7v72 and 7,b7 in subparagraph 7,a77iv71 by striking fiscal year #bjbj and inserting fiscal year #bjbc2 and 7#d7 in paragraph 7#d71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7b7 ,reauthorization ,section #gch;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjbb and inserting #bjbg2 and 7#b7 in paragraph 7#e71 by striking #bjbb and inserting #bjbg4 #bjje4 ,conformity assessment pilot program ,section #ead7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is amended to read as follows3 7d7 ,accreditation scheme for conformity assessment 7#a7 ,in general ,the ,secretary shall establish a program under which-- 7,a7 testing laboratories meeting criteria specified in guidance by the ,secretary may be accredited1 by accreditation bodies meeting criteria specified in guidance by the ,secretary1 to conduct testing to support the assessment of the conformity of a device to certain standards recognized under this section2 and 7,b7 subject to paragraph 7#b71 results from tests conducted to support the assessment of conformity of devices as described in subparagraph 7,a7 conducted by testing laboratories accredited pursuant to this subsection shall be accepted by the ,secretary for purposes of demonstrating such conformity unless the ,secretary finds that certain results of such tests should not be so accepted4 7#b7 ,secretarial review of accredited laboratory results ,the ,secretary may-- 7,a7 review the results of tests conducted by testing laboratories accredited pursuant to this subsection1 including by conducting periodic audits of such results or of the processes of accredited bodies or testing laboratories2 7,b7 following such review1 take additional measures under this ,act1 as the ,secretary determines appropriate1 such as-- 7i7 suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph 7#a77;,a72 or 7ii7 requesting additional information with respect to a device2 and 7,c7 if the ,secretary becomes aware of information materially bearing on the safety or effectiveness of a device for which an assessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection1 take such additional measures under this ,act1 as the ,secretary determines appropriate1 such as-- 7i7 suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph 7#a77;,a72 or 7ii7 requesting additional information with regard to such device4 7#c7 ,report ,the ,secretary shall make available on the internet website of the ,food and ,drug ,administration an annual report on the progress of the program under this subsection4 4 #bjjf4 ,reauthorization of third-party review program ,section #ebc7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7c77 is amended by striking ,october #a and inserting ,december #ag4 #bjjg4 ,sunset dates 7a7 ,authorization ,sections #gcg and #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;j7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gch;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provisions ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #baj of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #bjjh4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq47 shall be assessed for all submissions listed in section #gch7;a77#b77;,a7 of such ,act received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #bjji4 ,savings clause ,notwithstanding the amendments made by this title1 part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to the submissions listed in section #gch7;a77#b77;,a7 of such ,act 7as defined in such part as of such day7 that on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 were received by the ,food and ,drug ,administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,iii ,fees ,relating to ,generic ,drugs #cjja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,generic ,drug ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized by the amendments made by this title will be dedicated to human generic drug activities1 as set forth in the goals identified for purposes of part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #cjjb4 ,authority to assess and use human generic drug fees 7a7 ,types of fees ,section #gdd;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking #bjah and inserting #bjbc2 7#b7 in paragraph 7#b77;,c71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#c7 in paragraph 7#c77;,b71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#d7 in paragraph 7#d77;,d71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 and 7#e7 in paragraph 7#e77;,d71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7b7 ,fee revenue amounts ,section #gdd;,b7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in the heading1 by striking #bjah and inserting #bjbc2 7ii7 by striking #bjah and inserting #bjbc2 and 7iii7 by striking #dic1fjj1jjj and inserting #ehb1ejj1jjj2 and 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,fiscal years #bjbd through #bjbg 7i7 ,in general ,for each of the fiscal years #bjbd through #bjbg1 fees under paragraphs 7#b7 through 7#e7 of subsection 7a7 shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause 7ii71 as adjusted pursuant to subsection 7c74 7ii7 ,base revenue amount ,the base revenue amount for a fiscal year referred to in clause 7i7 is equal to the total revenue amount established under this paragraph for the previous fiscal year1 not including any adjustments made for such previous fiscal year under subsection 7c77#c74 2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,c71 by striking one-third the amount and inserting twenty-four percent2 7,b7 in subparagraph 7,d71 by striking ,seven percent and inserting ,six percent2 and 7,c7 in subparagraph 7,e77i71 by striking ,thirty-five percent and inserting ,thirty-six percent4 7c7 ,adjustments ,section #gdd;,b7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking #bjai and inserting #bjbd2 and 7ii7 by striking to equal the product of the total revenues established in such notice for the prior fiscal year multiplied and inserting to equal the base revenue amount for the fiscal year 7as specified in subsection 7b77#a77;,b77ii77 multiplied2 and 7,b7 in subparagraph 7,c71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 and 7#b7 by striking paragraph 7#b7 and inserting the following3 7#b7 ,capacity planning adjustment 7,a7 ,in general ,beginning with fiscal year #bjbd1 the ,secretary shall1 in addition to the adjustment under paragraph 7#a71 further increase the fee revenue and fees under this section for a fiscal year1 in accordance with this paragraph1 to reflect changes in the resource capacity needs of the ,secretary for human generic drug activities4 7,b7 ,capacity planning methodology ,the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7i7 be derived from the methodology and recommendations made in the report titled ,independent ,evaluation of the ,,gdufa ,resource ,capacity ,planning ,adjustment ,methodology3 ,evaluation and ,recommendations announced in the ,federal ,register on ,august #c1 #bjbj 7#he ,fed4 ,reg4 #dffeh72 and 7ii7 incorporate approaches and attributes determined appropriate by the ,secretary1 including approaches and attributes made in such report1 except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section ,,viii4,b4#b4;e4 of the letters described in section #cjja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjbb4 7,c7 ,limitations 7i7 ,in general ,under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection 7b77#a77;,b77ii7 7the base revenue amount for the fiscal year7 and paragraph 7#a7 7the dollar amount of the inflation adjustment for the fiscal year74 7ii7 ,additional limitation ,an adjustment under this paragraph shall not exceed #c percent of the sum described in clause 7i7 for the fiscal year1 except that such limitation shall be #d percent if-- 7,i7 for purposes of a fiscal year #bjbd adjustment1 the ,secretary determines that during the period from ,april #a1 #bjba1 through ,march #ca1 #bjbc-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1jjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as that term is defined in section ,,xi of the letters described in section #cjja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjbb72 7,,ii7 for purposes of a fiscal year #bjbe adjustment1 the ,secretary determines that during the period from ,april #a1 #bjbb1 through ,march #ca1 #bjbd-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined72 7,,iii7 for purposes of a fiscal year #bjbf adjustment1 the ,secretary determines that during the period from ,april #a1 #bjbc1 through ,march #ca1 #bjbe-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined72 and 7,,iv7 for purposes of a fiscal year #bjbg adjustment1 the ,secretary determines that during the period from ,april #a1 #bjbd1 through ,march #ca1 #bjbf-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined74 7,d7 ,publication in ,federal ,register ,the ,secretary shall publish in the ,federal ,register notice referred to in subsection 7a7 the fee revenue and fees resulting from the adjustment and the methodology under this paragraph4 7#c7 ,operating reserve adjustment 7,a7 ,in general ,for fiscal year #bjbd and each subsequent fiscal year1 the ,secretary may1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees under this section for such fiscal year if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph 7,b7 with respect to that fiscal year4 7,b7 ,number of weeks ,the number of weeks specified in this subparagraph is-- 7i7 #h weeks for fiscal year #bjbd2 7ii7 #i weeks for fiscal year #bjbe2 and 7iii7 #aj weeks for each of fiscal year #bjbf and #bjbg4 7,c7 ,decrease ,if the ,secretary has carryover balances for human generic drug activities in excess of #ab weeks of the operating reserves referred to in subparagraph 7,a71 the ,secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than #ab weeks of such operating reserves4 7,d7 ,rationale for adjustment ,if an adjustment under this paragraph is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under subsection 7a7 publishing the fee revenue and fees for the fiscal year involved4 4 7d7 ,annual fee setting ,section #gdd;,b7d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77#a77 is amended-- 7#a7 in the paragraph heading1 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 and 7#b7 by striking more than #fj days before the first day of each of fiscal years #bjah through #bjbb and inserting later than #fj days before the first day of each of fiscal years #bjbc through #bjbg4 7e7 ,effect of failure to pay fees ,the heading of paragraph 7#c7 of section #gdd;,b7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is amended by striking and prior approval supplement fee4 7f7 ,crediting and availability of fees ,section #gdd;,b7i77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77#c77 is amended by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg4 #cjjc4 ,reauthorization2 reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7#a7 in subsection 7a77#a71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 7#b7 by striking ,generic ,drug ,user ,fee ,amendments of #bjag each place it appears and inserting ,generic ,drug ,user ,fee ,amendments of #bjbb2 7#c7 in subsection 7a77#b71 by striking ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter and inserting ,not later than #cj calendar days after the end of each quarter of each fiscal year for which fees are collected under this part2 7#d7 in subsection 7a77#c71 by striking ,beginning with fiscal year #bjbj1 the and inserting ,the2 7#e7 in subsection 7b71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 7#f7 in subsection 7c71 by striking ,beginning with fiscal year #bjah1 for and inserting ,for2 and 7#g7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking fiscal year #bjbb and inserting fiscal year #bjbg2 and 7,b7 in paragraph 7#e71 by striking ,january #ae1 #bjbb and inserting ,january #ae1 #bjbg4 #cjjd4 ,sunset dates 7a7 ,authorization ,sections #gdd;,a and #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #cje of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #cjje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq47 shall be assessed for all abbreviated new drug applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #cjjf4 ,savings clause ,notwithstanding the amendments made by this title1 part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to abbreviated new drug applications 7as defined in such part as of such day7 that were received by the ,food and ,drug ,administration within the meaning of section #eje7;j77#e77;,a7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,a771 prior approval supplements that were submitted1 and drug master files for ,type ,,ii active pharmaceutical ingredients that were first referenced on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,iv ,fees ,relating to ,biosimilar ,biological ,products #djja4 ,short title2 finding 7a7 ,short ,title ,this title may be cited as the ,biosimilar ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized by the amendments made by this title will be dedicated to expediting the process for the review of biosimilar biological product applications1 including postmarket safety activities1 as set forth in the goals identified for purposes of part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #djjb4 ,definitions 7a7 ,adjustment factor ,section #gdd;,g7#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7a77 is amended to read as follows3 7#a7 ,the term adjustment factor applicable to a fiscal year is the ,consumer ,price ,index for urban consumers 7,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 ,not ,seasonally ,adjusted2 ,all items7 for ,september of the preceding fiscal year divided by such ,index for ,september #bjaa4 4 7b7 ,biosimilar biological product application ,section #gdd;,g7#d77;,b77iii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7d77;,b77iii77 is amended-- 7#a7 by striking subclause 7,,ii7 7relating to an allergenic extract product72 and 7#b7 by redesignating subclauses 7,,iii7 and 7,,iv7 as subclauses 7,,ii7 and 7,,iii71 respectively4 #djjc4 ,authority to assess and use biosimilar biological product fees 7a7 ,types of fees 7#a7 ,in general ,the matter preceding paragraph 7#a7 in section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended by striking fiscal year #bjah and inserting fiscal year #bjbc4 7#b7 ,initial biosimilar biological product development fee ,clauses 7iv77,i7 and 7v77,,ii7 of section #gdd;,h7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,a77 are each amended by striking #e days and inserting #g days4 7#c7 ,annual biosimilar biological product development fee ,section #gdd;,h7a77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,b77 is amended-- 7,a7 in clause 7i71 by inserting before the period at the end the following3 1 except that1 in the case that such product 7including1 where applicable1 ownership of the relevant investigational new drug application7 is transferred to a licensee1 assignee1 or successor of such person1 and written notice of such transfer is provided to the ,secretary1 such licensee1 assignee1 or successor shall pay the annual biosimilar biological product development fee2 7,b7 in clause 7iii7-- 7i7 in subclause 7,i71 by striking or at the end2 7ii7 in subclause 7,,ii71 by striking the period at the end and inserting 2 or2 and 7iii7 by adding at the end the following3 7,,iii7 been administratively removed from the biosimilar biological product development program for the product under subparagraph 7,e77v74 2 and 7,c7 in clause 7iv71 by striking is accepted for filing on or after ,october #a of such fiscal year and inserting is subsequently accepted for filing4 7#d7 ,reactivation fee ,section #gdd;,h7a77#a77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,d77 is amended to read as follows3 7,d7 ,reactivation fee 7i7 ,in general ,a person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph 7,c71 or who has been administratively removed from such program for a product under subparagraph 7,e77v71 shall1 if the person seeks to resume participation in such program1 pay all annual biosimilar biological product development fees previously assessed for such product and still owed and a fee 7referred to in this section as reactivation fee7 by the earlier of the following3 7,i7 ,not later than #g days after the ,secretary grants a request by such person for a biosimilar biological product development meeting for the product 7after the date on which such participation was discontinued or the date of administrative removal1 as applicable74 7,,ii7 ,upon the date of submission 7after the date on which such participation was discontinued or the date of administrative removal1 as applicable7 by such person of an investigational new drug application describing an investigation that the ,secretary determines is intended to support a biosimilar biological product application for that product4 7ii7 ,application of annual fee ,a person that pays a reactivation fee for a product shall pay for such product1 beginning in the next fiscal year1 the annual biosimilar biological product development fee under subparagraph 7,b71 except that1 in the case that such product 7including1 where applicable1 ownership of the relevant investigational new drug application7 is transferred to a licensee1 assignee1 or successor of such person1 and written notice of such transfer is provided to the ,secretary1 such licensee1 assignee1 or successor shall pay the annual biosimilar biological product development fee4 4 7#e7 ,effect of failure to pay fees ,section #gdd;,h7a77#a77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,e77 is amended by adding at the end the following3 7v7 ,administrative removal from the biosimilar biological product development program ,if a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph 7,b7 for a period of #b consecutive fiscal years1 the ,secretary may administratively remove such person from the biosimilar biological product development program for the product4 ,at least #cj days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause1 the ,secretary shall provide written notice to such person of the intended administrative removal4 4 7#f7 ,biosimilar biological product application fee ,section #gdd;,h7a77#b77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#b77;,d77 is amended by inserting after or was withdrawn the following3 prior to approval4 7#g7 ,biosimilar biological product program fee ,section #gdd;,h7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#c77 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7i71 by striking and at the end2 7ii7 by redesignating clause 7ii7 as clause 7iii72 and 7iii7 by inserting after clause 7i7 the following3 7ii7 may be dispensed only under prescription pursuant to section #ejc7;b72 and 2 and 7,b7 by adding at the end the following3 7,e7 ,movement to discontinued list 7i7 ,date of inclusion ,if a written request to place a product on the list referenced in subparagraph 7,a7 of discontinued biosimilar biological products is submitted to the ,secretary on behalf of an applicant1 and the request identifies the date the product is1 or will be1 withdrawn from sale1 then for purposes of assessing the biosimilar biological product program fee1 the ,secretary shall consider such product to have been included on such list on the later of-- 7,i7 the date such request was received2 or 7,,ii7 if the product will be withdrawn from sale on a future date1 such future date when the product is withdrawn from sale4 7ii7 ,treatment as withdrawn from sale ,for purposes of clause 7i71 a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product1 whether or not the applicant has ordered recall of all previously distributed lots of the product1 except that a routine1 temporary interruption in supply shall not render a product withdrawn from sale4 7iii7 ,special rule for products removed from discontinued list ,if a biosimilar biological product that is identified in a biosimilar biological product application approved as of ,october #a of a fiscal year appears1 as of ,october #a of such fiscal year1 on the list referenced in subparagraph 7,a7 of discontinued biosimilar biological products1 and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list1 except as provided in subparagraph 7,d71 each person who is named as the applicant in a biosimilar biological product application with respect to such product shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection 7c77#e7 for such biosimilar biological product4 ,notwithstanding subparagraph 7,b71 such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for each fiscal year4 4 7#h7 ,biosimilar biological product fee ,section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended by striking paragraph 7#d74 7b7 ,fee revenue amounts ,subsection 7b7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is amended-- 7#a7 by striking paragraph 7#a72 7#b7 by redesignating paragraphs 7#b7 through 7#d7 as paragraphs 7#a7 through 7#c71 respectively2 7#c7 by amending paragraph 7#a7 7as so redesignated7 to read as follows3 7#a7 ,in general ,for each of the fiscal years #bjbc through #bjbg1 fees under subsection 7a7 shall1 except as provided in subsection 7c71 be established to generate a total revenue amount equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the strategic hiring and retention adjustment 7as determined under subsection 7c77#b772 7,d7 the dollar amount equal to the capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#c772 7,e7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#d772 7,f7 for fiscal year #bjbc an additional amount of #d1dbh1hhf2 and 7,g7 for fiscal year #bjbd an additional amount of #cbj1efi4 2 7#d7 in paragraph 7#b7 7as so redesignated7-- 7,a7 in the paragraph heading1 by striking 2 limitations on fee amounts2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,b7 and 7,c71 respectively2 and 7#e7 by amending paragraph 7#c7 7as so redesignated7 to read as follows3 7#c7 ,annual base revenue ,for purposes of paragraph 7#a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjbc1 #dc1cgf1ibb2 and 7,b7 for fiscal years #bjbd through #bjbg1 the dollar amount of the total revenue amount established under paragraph 7#a7 for the previous fiscal year1 excluding any adjustments to such revenue amount under subsection 7c77#d74 4 7c7 ,adjustments2 annual fee setting ,section #gdd;,h7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;c77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking subsection 7b77#b77;,b7 and inserting subsection 7b77#a77;,b72 and 7ii7 in clause 7i71 by striking subsection 7b7 and inserting subsection 7b77#a77;,a72 and 7,b7 in subparagraph 7,b77ii71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 7#b7 by striking paragraphs 7#b7 through 7#d7 and inserting the following3 7#b7 ,strategic hiring and retention adjustment ,for each fiscal year1 after the annual base revenue under subsection 7b77#a77;,a7 is adjusted for inflation in accordance with paragraph 7#a71 the ,secretary shall further increase the fee revenue and fees by #aej1jjj4 7#c7 ,capacity planning adjustment 7,a7 ,in general ,for each fiscal year1 the ,secretary shall1 in addition to the adjustments under paragraphs 7#a7 and 7#b71 further adjust the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the ,secretary for the process for the review of biosimilar biological product applications4 7,b7 ,methodology ,for purposes of this paragraph1 the ,secretary shall employ the capacity planning methodology utilized by the ,secretary in setting fees for fiscal year #bjba1 as described in the notice titled ,biosimilar ,user ,fee ,rates for ,fiscal ,year #bjba published in the ,federal ,register on ,august #d1 #bjbj 7#he ,fed4 ,reg4 #dgbbj74 ,the workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and1 as feasible1 additional activities that are directly related to the direct review of biosimilar biological product applications and supplements1 including additional formal meeting types1 the direct review of postmarketing commitments and requirements1 the direct review of risk evaluation and mitigation strategies1 and the direct review of annual reports for approved biosimilar biological products4 ,subject to the exceptions in the preceding sentence1 the ,secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities1 including those activities that the ,secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year #bjba4 7,c7 ,limitations ,under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections 7b77#a77;,a7 7the annual base revenue for the fiscal year71 7b77#a77;,b7 7the dollar amount of the inflation adjustment for the fiscal year71 and 7b77#a77;,c7 7the dollar amount of the strategic hiring and retention adjustment74 7,d7 ,publication in ,federal ,register ,the ,secretary shall publish in the ,federal ,register notice under paragraph 7#e7 the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph4 7#d7 ,operating reserve adjustment 7,a7 ,increase ,for fiscal year #bjbc and subsequent fiscal years1 the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees if such an adjustment is necessary to provide for at least #aj weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications4 7,b7 ,decrease 7i7 ,fiscal year #bjbc ,for fiscal year #bjbc1 if the ,secretary has carryover balances for such process in excess of #cc weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #cc weeks of such operating reserves4 7ii7 ,fiscal year #bjbd ,for fiscal year #bjbd1 if the ,secretary has carryover balances for such process in excess of #bg weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #bg weeks of such operating reserves4 7iii7 ,fiscal year #bjbe and subsequent fiscal years ,for fiscal year #bjbe and subsequent fiscal years1 if the ,secretary has carryover balances for such process in excess of #ba weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #ba weeks of such operating reserves4 7,c7 ,federal ,register notice ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e77;,b7 establishing fee revenue and fees for the fiscal year involved4 2 and 7#c7 in paragraph 7#e71 in the matter preceding subparagraph 7,a71 by striking #bjah and inserting #bjbc4 7d7 ,crediting and availability of fees ,subsection 7f77#c7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7e7 ,written requests for waivers and returns2 disputes concerning fees ,section #gdd;,h7h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;h77 is amended to read as follows3 7h7 ,written requests for waivers and returns2 disputes concerning fees ,to qualify for consideration for a waiver under subsection 7d71 or for the return of any fee paid under this section1 including if the fee is claimed to have been paid in error1 a person shall submit to the ,secretary a written request justifying such waiver or return and1 except as otherwise specified in this section1 such written request shall be submitted to the ,secretary not later than #ahj days after such fee is due4 ,a request submitted under this paragraph shall include any legal authorities under which the request is made4 4 #djjd4 ,reauthorization2 reporting requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is amended-- 7#a7 in subsection 7a77#a71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 7#b7 by striking ,biosimilar ,user ,fee ,amendments of #bjag each place it appears and inserting ,biosimilar ,user ,fee ,amendments of #bjbb2 7#c7 in subsection 7a77#b71 by striking ,beginning with fiscal year #bjah1 the and inserting ,the2 7#d7 in subsection 7a77#c77;,a71 by striking ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter and inserting ,not later than #cj calendar days after the end of each quarter of each fiscal year for which fees are collected under this part2 7#e7 in subsection 7b71 by striking ,not later than #abj days after the end of fiscal year #bjah and each subsequent fiscal year for which fees are collected under this part and inserting ,not later than #abj days after the end of each fiscal year for which fees are collected under this part2 7#f7 in subsection 7c71 by striking ,beginning with fiscal year #bjah1 and for and inserting ,for2 and 7#g7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking fiscal year #bjbb and inserting fiscal year #bjbg2 and 7,b7 in paragraph 7#c71 by striking ,january #ae1 #bjbb and inserting ,january #ae1 #bjbg4 #djje4 ,sunset dates 7a7 ,authorization ,sections #gdd;,g and #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea1 #cgi;j-#eb7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting ,requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous ,sunset ,provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #dje of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #djjf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq47 shall be assessed for all biosimilar biological product applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #djjg4 ,savings clause ,notwithstanding the amendments made by this title1 part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to biosimilar biological product applications and supplements 7as defined in such part as of such day7 that were accepted by the ,food and ,drug ,administration for filing on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,v ,reauthorization of other provisions #ejja4 ,reauthorization of the best pharmaceuticals for children program ,section #dji;,i7d77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is amended by striking #be1jjj1jjj for each of fiscal years #bjah through #bjbb and inserting #e1bgc1igc for the period beginning on ,october #a1 #bjbb and ending on ,december #af1 #bjbb4 #ejjb4 ,reauthorization of the humanitarian device exemption incentive ,section #ebj7m77#f77;,a77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is amended by striking ,october #a and inserting ,december #ag4 #ejjc4 ,reauthorization of the pediatric device consortia program ,section #cje7;e7 of the ,food and ,drug ,administration ,amendments ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is amended by striking #e1bej1jjj for each of fiscal years #bjah through #bjbb and inserting #a1ajg1ecd for the period beginning on ,october #a1 #bjbb1 and ending on ,december #af1 #bjbb4 #ejjd4 ,reauthorization of provision pertaining to drugs containing single enantiomers ,section #eje7u77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7u77#d77 is amended by striking ,october #a and inserting ,december #ag4 #ejje4 ,reauthorization of the critical path public-private partnership ,section #eff7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is amended by striking #f1jjj1jjj for each of fiscal years #bjah through #bjbb and inserting #a1bfe1gec for the period beginning on ,october #a1 #bjbb and ending on ,december #af1 #bjbb4 #ejjf4 ,reauthorization of orphan drug grants ,section #e7;c7 of the ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is amended by striking #cj1jjj1jjj for each of fiscal years #bjah through #bjbb and inserting #f1cbh1gfg for the period beginning on ,october #a1 #bjbb1 and ending on ,december #af1 #bjbb4 #ejjg4 ,reauthorization of certain device inspections ,section #gjd7;g77#aa7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77#aa77 is amended by striking ,october #a and inserting ,december #ag4 #ejjh4 ,reauthorization of reporting requirements related to pending generic drug applications and priority review applications ,section #hjg of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 is amended1 in the matter preceding paragraph 7#a71 by striking ,october #a and inserting ,december #af4 ,g ,hermit's ,peak_/,calf ,canyon ,fire ,assistance ,act #aja4 ,short title ,this division may be cited as the ,hermit's ,peak_/,calf ,canyon ,fire ,assistance ,act4 #ajb4 ,findings and purposes 7a7 ,findings ,congress finds that-- 7#a7 on ,april #f1 #bjbb1 the ,forest ,service initiated the ,las ,dispensas-,gallinas prescribed burn on ,federal land in the ,santa ,fe ,national ,forest in ,san ,miguel ,county1 ,new ,mexico1 when erratic winds were prevalent in the area that was also suffering from severe drought after many years of insufficient precipitation2 7#b7 on ,april #f1 #bjbb1 the prescribed burn1 which became known as the ,hermit's ,peak ,fire1 exceeded the containment capabilities of the ,forest ,service1 was declared a wildfire1 and spread to other ,federal and non-,federal land2 7#c7 on ,april #ai1 #bjbb1 the ,calf ,canyon ,fire1 also in ,san ,miguel ,county1 ,new ,mexico1 began burning on ,federal land and was later identified as the result of a pile burn in ,january #bjbb that remained dormant under the surface before reemerging2 7#d7 on ,april #bg1 #bjbb1 the ,hermit's ,peak ,fire and the ,calf ,canyon ,fire merged1 and both fires were reported as the ,hermit's ,peak ,fire or the ,hermit's ,peak_/,calf ,canyon ,fire1 which shall be referred to hereafter as the ,hermit's ,peak_/,calf ,canyon ,fire2 7#e7 by ,may #b1 #bjbb1 the fire had grown in size and caused evacuations in multiple villages and communities in ,san ,miguel ,county and ,mora ,county1 including in the ,san ,miguel county jail1 the ,state's psychiatric hospital1 the ,united ,world ,college1 and ,new ,mexico ,highlands ,university2 7#f7 on ,may #d1 #bjbb1 the ,president issued a major disaster declaration for the counties of ,colfax1 ,mora1 and ,san ,miguel1 ,new ,mexico2 7#g7 on ,may #bj1 #bjbb1 ,u4,s4 ,forest ,service ,chief ,randy ,moore ordered a #ij-;day review of prescribed burn policies to reduce the risk of wildfires and ensure the safety of the communities involved2 7#h7 the ,u4,s4 ,forest ,service has assumed responsibility for the ,hermit's ,peak_/,calf ,canyon ,fire2 7#i7 the fire resulted in the loss of ,federal1 ,state1 local1 ,tribal1 and private property2 and 7#aj7 the ,united ,states should compensate the victims of the ,hermit's ,peak_/,calf ,canyon ,fire4 7b7 ,purposes ,the purposes of this ,act are-- 7#a7 to compensate victims of the ,hermit's ,peak_/,calf ,canyon ,fire1 for injuries resulting from the fire2 and 7#b7 to provide for the expeditious consideration and settlement of claims for those injuries4 #ajc4 ,definitions ,in this ,act3 7#a7 ,administrator ,the term ,administrator means-- 7,a7 the ,administrator of the ,federal ,emergency ,management ,agency2 or 7,b7 if a ,manager is appointed under section #ajd7;a77#c71 the ,manager4 7#b7 ,hermit's peak_/calf canyon fire ,the term ,hermit's ,peak_/,calf ,canyon ,fire means-- 7,a7 the fire resulting from the initiation by the ,forest ,service of a prescribed burn in the ,santa ,fe ,national ,forest in ,san ,miguel ,county1 ,new ,mexico1 on ,april #f1 #bjbb2 7,b7 the pile burn holdover resulting from the prescribed burn by the ,forest ,service1 which reemerged on ,april #ai1 #bjbb2 and 7,c7 the merger of the two fires described in subparagraphs 7,a7 and 7,b71 reported as the ,hermit's ,peak ,fire or the ,hermit's ,peak ,fire_/,calf ,canyon ,fire4 7#c7 ,indian tribe ,the term ,indian ,tribe means the recognized governing body of any ,indian or ,alaska ,native ,tribe1 band1 nation1 pueblo1 village1 community1 component band1 or component reservation individually identified 7including parenthetically7 in the list published most recently as of the date of enactment of this ,act pursuant to section #ajd of the ,federally ,recognized ,indian ,tribe ,list ,act of #aiid 7#be ,u4,s4,c4 #eaca74 7#d7 ,injured person ,the term injured person means-- 7,a7 an individual1 regardless of the citizenship or alien status of the individual2 or 7,b7 an ,indian ,tribe1 corporation1 ,tribal corporation1 partnership1 company1 association1 county1 township1 city1 ,state1 school district1 or other non-,federal entity 7including a legal representative7 that suffered injury resulting from the ,hermit's ,peak_/,calf ,canyon ,fire4 7#e7 ,injury ,the term injury has the same meaning as the term injury or loss of property1 or personal injury or death as used in section #acdf7;b77#a7 of title #bh1 ,united ,states ,code4 7#f7 ,manager ,the term ,manager means an ,independent ,claims ,manager appointed under section #ajd7;a77#c74 7#g7 ,office ,the term ,office means the ,office of ,hermit's ,peak_/,calf ,canyon ,fire ,claims established by section #ajd7;a77#b74 7#h7 ,tribal entity ,the term ,tribal entity includes any ,indian ,tribe1 tribal organization1 ,indian-controlled organization serving ,indians1 ,native ,hawaiian organization1 or ,alaska ,native entity1 as such terms are defined or used in section #aff of the ,workforce ,innovation and ,opportunity ,act 7#bi ,u4,s4,c4 #cbba74 #ajd4 ,compensation for victims of hermit's peak_/calf canyon fire 7a7 ,in general 7#a7 ,compensation ,each injured person shall be eligible to receive from the ,united ,states compensation for injury suffered by the injured person as a result of the ,hermit's ,peak_/,calf ,canyon ,fire1 subject to the availability of appropriations and subject to the ,administrator making the determinations required under subsection 7d74 7#b7 ,office of hermit's peak_/calf canyon fire claims 7,a7 ,in general ,there is established within the ,federal ,emergency ,management ,agency an ,office of ,hermit's ,peak_/,calf ,canyon ,fire ,claims4 7,b7 ,purpose ,the ,office shall receive1 process1 and pay claims in accordance with this ,act4 7,c7 ,funding ,the ,office-- 7i7 shall be funded from funds made available to the ,administrator for carrying out this section2 7ii7 may appoint and fix the compensation of such temporary personnel as may be necessary1 without regard to the provisions of title #e1 ,united ,states ,code1 governing appointments in competitive service2 and 7iii7 may reimburse other ,federal agencies for claims processing support and assistance4 7#c7 ,option to appoint independent claims manager ,the ,administrator may appoint an ,independent ,claims ,manager to-- 7,a7 head the ,office2 and 7,b7 assume the duties of the ,administrator under this ,act4 7#d7 ,detail ,upon the request of the ,administrator1 the head of any ,federal department or agency may detail1 on a reimbursable basis1 any of the personnel of that department or agency to the ,federal ,emergency ,management ,agency to assist the ,agency in carrying out the duties under this ,act4 7b7 ,submission of claims ,not later than #b years after the date on which regulations are first promulgated under subsection 7f71 an injured person may submit to the ,administrator a written claim for #a or more injuries suffered by the injured person in accordance with such requirements as the ,administrator determines to be appropriate4 7c7 ,investigation of claims 7#a7 ,in general ,in accordance with subsection 7d71 the ,administrator shall1 on behalf of the ,united ,states1 investigate1 consider1 ascertain1 adjust1 determine1 grant1 deny1 or settle any claim for money damages asserted under subsection 7b74 7#b7 ,applicability of state law ,except as otherwise provided in this ,act1 the laws of the ,state of ,new ,mexico shall apply to the calculation of damages under subsection 7d77#d74 7#c7 ,extent of damages ,any payment under this ,act-- 7,a7 shall be limited to actual compensatory damages measured by injuries suffered2 and 7,b7 shall not include-- 7i7 interest before settlement or payment of a claim2 or 7ii7 punitive damages4 7d7 ,payment of claims 7#a7 ,determination and payment of amount 7,a7 ,in general 7i7 ,payment ,not later than #ahj days after the date on which a claim is submitted under this ,act1 the ,administrator shall determine and fix the amount1 if any1 to be paid for the claim4 7ii7 ,priority ,the ,administrator1 to the maximum extent practicable1 shall pay subrogation claims submitted under this ,act only after paying claims submitted by injured parties that are not insurance companies seeking payment as subrogees4 7,b7 ,parameters of determination ,in determining and settling a claim under this ,act1 the ,administrator shall determine only-- 7i7 whether the claimant is an injured person2 7ii7 whether the injury that is the subject of the claim resulted from the ,hermit's ,peak_/,calf ,canyon ,fire2 7iii7 whether the person or persons are otherwise eligible to receive any amount determined under clause 7iv72 and 7iv7 whether sufficient funds are available for payment and1 if so1 the amount1 if any1 to be allowed and paid under this ,act4 7,c7 ,insurance and other benefits 7i7 ,in general ,in determining the amount of1 and paying1 a claim under this ,act1 to prevent recovery by a claimant in excess of actual compensatory damages1 the ,administrator shall reduce the amount to be paid for the claim by an amount that is equal to the total of insurance benefits 7excluding life insurance benefits7 or other payments or settlements of any nature that were paid1 or will be paid1 with respect to the claim4 7ii7 ,government loans ,this subparagraph shall not apply to the receipt by a claimant of any government loan that is required to be repaid by the claimant4 7#b7 ,partial payment 7,a7 ,in general ,at the request of a claimant1 the ,administrator may make #a or more advance or partial payments1 subject to the determination required under paragraph 7#a77;,b71 before the final settlement of a claim1 including final settlement on any portion or aspect of a claim that is determined to be severable4 7,b7 ,judicial decision ,if a claimant receives a partial payment on a claim under this ,act1 but further payment on the claim is subsequently denied by the ,administrator1 the claimant may-- 7i7 seek judicial review under subsection 7i72 and 7ii7 keep any partial payment that the claimant received1 unless the ,administrator determines that the claimant-- 7,i7 was not eligible to receive the compensation2 or 7,,ii7 fraudulently procured the compensation4 7#c7 ,rights of insurer or other third party ,if an insurer or other third party pays any amount to a claimant to compensate for an injury described in subsection 7a71 the insurer or other third party shall be subrogated to any right that the claimant has to receive any payment under this ,act or any other law4 7#d7 ,allowable damages 7,a7 ,loss of property ,a claim that is paid for loss of property under this ,act may include otherwise uncompensated damages resulting from the ,hermit's ,peak_/,calf ,canyon ,fire for-- 7i7 an uninsured or underinsured property loss2 7ii7 a decrease in the value of real property2 7iii7 damage to physical infrastructure1 including irrigation infrastructure such as acequia systems2 7iv7 a cost resulting from lost subsistence from hunting1 fishing1 firewood gathering1 timbering1 grazing1 or agricultural activities conducted on land damaged by the ,hermit's ,peak_/,calf ,canyon ,fire2 7v7 a cost of reforestation or revegetation on ,tribal or non-,federal land1 to the extent that the cost of reforestation or revegetation is not covered by any other ,federal program2 and 7vi7 any other loss that the ,administrator determines to be appropriate for inclusion as loss of property4 7,b7 ,business loss ,a claim that is paid for injury under this ,act may include damages resulting from the ,hermit's ,peak_/,calf ,canyon ,fire for the following types of otherwise uncompensated business loss3 7i7 ,damage to tangible assets or inventory1 including natural resources4 7ii7 ,business interruption losses4 7iii7 ,overhead costs4 7iv7 ,employee wages for work not performed4 7v7 ,loss of business net income4 7vi7 ,any other loss that the ,administrator determines to be appropriate for inclusion as business loss4 7,c7 ,financial loss ,a claim that is paid for injury under this ,act may include damages resulting from the ,hermit's ,peak_/,calf ,canyon ,fire for the following types of otherwise uncompensated financial loss3 7i7 ,increased mortgage interest costs4 7ii7 ,an insurance deductible4 7iii7 ,a temporary living or relocation expense4 7iv7 ,lost wages or personal income4 7v7 ,emergency staffing expenses4 7vi7 ,debris removal and other cleanup costs4 7vii7 ,costs of reasonable efforts1 as determined by the ,administrator1 to reduce the risk of wildfire1 flood1 or other natural disaster in the counties impacted by the ,hermit's ,peak_/,calf ,canyon ,fire to risk levels prevailing in those counties before the ,hermit's ,peak_/,calf ,canyon ,fire1 that are incurred not later than the date that is #c years after the date on which the regulations under subsection 7f7 are first promulgated4 7viii7 ,a premium for flood insurance that is required to be paid on or before ,may #ca1 #bjbd1 if1 as a result of the ,hermit's ,peak_/,calf ,canyon ,fire1 a person that was not required to purchase flood insurance before the ,hermit's ,peak_/,calf ,canyon ,fire is required to purchase flood insurance4 7ix7 ,a disaster assistance loan received from the ,small ,business ,administration4 7x7 ,any other loss that the ,administrator determines to be appropriate for inclusion as financial loss4 7e7 ,acceptance of award ,the acceptance by a claimant of any payment under this ,act1 except an advance or partial payment made under subsection 7d77#b71 shall-- 7#a7 be final and conclusive on the claimant1 with respect to all claims arising out of or relating to the same subject matter2 and 7#b7 constitute a complete release of all claims against the ,united ,states 7including any agency or employee of the ,united ,states7 under chapter #aga of title #bh1 ,united ,states ,code 7commonly known as the ,federal ,tort ,claims ,act71 or any other ,federal or ,state law1 arising out of or relating to the same subject matter4 7f7 ,regulations and public information 7#a7 ,regulations ,notwithstanding any other provision of law1 not later than #de days after the date of enactment of this ,act1 the ,administrator shall promulgate and publish in the ,federal ,register interim final regulations for the processing and payment of claims under this ,act4 7#b7 ,public information 7,a7 ,in general ,at the time at which the ,administrator promulgates regulations under paragraph 7#a71 the ,administrator shall publish1 online and in print1 in newspapers of general circulation in the ,state of ,new ,mexico1 a clear1 concise1 and easily understandable explanation1 in ,english and ,spanish1 of-- 7i7 the rights conferred under this ,act2 and 7ii7 the procedural and other requirements of the regulations promulgated under paragraph 7#a74 7,b7 ,dissemination through other media ,the ,administrator shall disseminate the explanation published under subparagraph 7,a7 through websites1 blogs1 social media1 brochures1 pamphlets1 radio1 television1 and other media that the ,administrator determines are likely to reach prospective claimants4 7g7 ,consultation ,in administering this ,act1 the ,administrator shall consult with the ,secretary of the ,interior1 the ,secretary of ,energy1 the ,secretary of ,agriculture1 the ,administrator of the ,small ,business ,administration1 other ,federal agencies1 and ,state1 local1 and ,tribal authorities1 as determined to be necessary by the ,administrator1 to-- 7#a7 ensure the efficient administration of the claims process2 and 7#b7 provide for local concerns4 7h7 ,election of remedy 7#a7 ,in general ,an injured person may elect to seek compensation from the ,united ,states for #a or more injuries resulting from the ,hermit's ,peak_/,calf ,canyon ,fire by-- 7,a7 submitting a claim under this ,act2 7,b7 filing a claim or bringing a civil action under chapter #aga of title #bh1 ,united ,states ,code 7commonly known as the ,federal ,tort ,claims ,act72 or 7,c7 bringing an authorized civil action under any other provision of law4 7#b7 ,effect of election ,in accordance with subsection 7e71 an election by an injured person to seek compensation in any manner described in paragraph 7#a7 shall be final and conclusive on the claimant with respect to all injuries resulting from the ,hermit's ,peak_/,calf ,canyon ,fire that are suffered by the claimant upon acceptance of an award4 7#c7 ,arbitration 7,a7 ,in general ,not later than #de days after the date of enactment of this ,act1 the ,administrator shall establish by regulation procedures under which a dispute regarding a claim submitted under this ,act may be settled by arbitration4 7,b7 ,arbitration as remedy ,on establishment of arbitration procedures under subparagraph 7,a71 an injured person that submits a disputed claim under this ,act may elect to settle the claim through arbitration4 7,c7 ,binding effect ,an election by an injured person to settle a claim through arbitration under this paragraph shall-- 7i7 be binding2 and 7ii7 preclude any exercise by the injured person of the right to judicial review of a claim described in subsection 7i74 7#d7 ,no effect on entitlements ,the value of compensation that may be provided under this ,act shall not be considered income or resources for any purpose under any ,federal1 ,state1 or local laws1 including laws relating to taxation1 welfare1 and public assistance programs1 and no ,state or political subdivision thereof shall decrease any assistance otherwise provided to an injured person because of the receipt of benefits under this ,act4 7i7 ,judicial review 7#a7 ,in general ,any claimant aggrieved by a final decision of the ,administrator under this ,act may1 not later than #fj days after the date on which the decision is issued1 bring a civil action in the ,united ,states ,district ,court for the ,district of ,new ,mexico1 to modify or set aside the decision1 in whole or in part4 7#b7 ,record ,the court shall hear a civil action under paragraph 7#a7 on the record made before the ,administrator4 7#c7 ,standard ,the decision of the ,administrator incorporating the findings of the ,administrator shall be upheld if the decision is supported by substantial evidence on the record considered as a whole4 7j7 ,attorney's and agent's fees 7#a7 ,in general ,no attorney or agent1 acting alone or in combination with any other attorney or agent1 shall charge1 demand1 receive1 or collect1 for services rendered in connection with a claim submitted under this ,act1 fees in excess of the limitations established under section #bfgh of title #bh1 ,united ,states ,code4 7#b7 ,violation ,an attorney or agent who violates paragraph 7#a7 shall be fined not more than #aj1jjj4 7k7 ,waiver of requirement for matching funds 7#a7 ,state and local project 7,a7 ,in general ,notwithstanding any other provision of law1 a ,state or local project that is determined by the ,administrator to be carried out in response to the ,hermit's ,peak_/,calf ,canyon ,fire under any ,federal program that applies to an area affected by the ,hermit's ,peak_/,calf ,canyon ,fire shall not be subject to any requirement for ,state or local matching funds to pay the cost of the project under the ,federal program4 7,b7 ,federal share ,the ,federal share of the costs of a project described in subparagraph 7,a7 shall be #ajj percent4 7#b7 ,other needs program assistance ,notwithstanding section #djh7;g77#b7 of the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act 7#db ,u4,s4,c4 #eagd7;g77#b771 for any emergency or major disaster declared by the ,president under that ,act for the ,hermit's ,peak_/,calf ,canyon ,fire1 the ,federal share of assistance provided under that section shall be #ajj percent4 7#c7 ,agricultural program assistance 7,a7 ,in general ,notwithstanding any other provision of law1 a ,state1 local1 or individual project that is determined by the ,secretary of ,agriculture to be carried out in response to the ,hermit's ,peak_/,calf ,canyon ,fire under any ,federal program that applies to an area affected by the ,hermit's ,peak_/,calf ,canyon ,fire shall not be subject to any requirement for ,state1 local1 or individual matching funds to pay the cost of the project under the ,federal program4 7,b7 ,federal share ,the ,federal share of the costs of a project described in subparagraph 7,a7 shall be #ajj percent4 7l7 ,applicability of debt collection requirements ,section #cgaa7;a7 of title #ca1 ,united ,states ,code1 shall not apply to any payment under this ,act1 unless-- 7#a7 there is evidence of civil or criminal fraud1 misrepresentation1 presentation of a false claim2 or 7#b7 a claimant was not eligible under subsection 7d77#b7 of this ,act to any partial payment4 7m7 ,indian compensation ,notwithstanding any other provision of law1 in the case of an ,indian ,tribe1 a ,tribal entity1 or a member of an ,indian ,tribe that submits a claim under this ,act-- 7#a7 the ,bureau of ,indian ,affairs shall have no authority over1 or any trust obligation regarding1 any aspect of the submission of1 or any payment received for1 the claim2 7#b7 the ,indian ,tribe1 ,tribal entity1 or member of an ,indian ,tribe shall be entitled to proceed under this ,act in the same manner and to the same extent as any other injured person2 and 7#c7 except with respect to land damaged by the ,hermit's ,peak_/,calf ,canyon ,fire that is the subject of the claim1 the ,bureau of ,indian ,affairs shall have no responsibility to restore land damaged by the ,hermit's ,peak_/,calf ,canyon ,fire4 7n7 ,report ,not later than #a year after the date of promulgation of regulations under subsection 7f77#a71 and annually thereafter1 the ,administrator shall submit to ,congress a report that describes the claims submitted under this ,act during the year preceding the date of submission of the report1 including1 for each claim-- 7#a7 the amount claimed2 7#b7 a brief description of the nature of the claim2 and 7#c7 the status or disposition of the claim1 including the amount of any payment under this ,act4 7o7 ,authorization of appropriations ,there are authorized to be appropriated such sums as are necessary to carry out this ,act4 ,secretary