,,ii ,calendar ,no4 #ffh #aagth ,,congress #b;d ,session ,s4 #acjf ,report ,no4 #aag-bfi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #bb1 #bjba,mr4 ,portman 7for himself1 ,mr4 ,peters1 and ,mrs4 ,gillibrand7 introduced the following bill2 which was read twice and referred to the ,committee on ,homeland ,security and ,governmental ,affairs ,december #ai1 #bjbb,reported by ,mr4 ,peters1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to provide for domestic sourcing of personal protective equipment1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,make ,,ppe in ,america ,act4 #b4 ,findings ,congress makes the following findings3 7#a7 ,the ,,covid-#ai pandemic has exposed the vulnerability of the ,united ,states supply chains for1 and lack of domestic production of1 personal protective equipment 7,,ppe74 7#b7 ,the ,united ,states requires a robust1 secure1 and wholly domestic ,,ppe supply chain to safeguard public health and national security4 7#c7 ,issuing a strategy that provides the government's anticipated needs over the next three years will enable suppliers to assess what changes1 if any1 are needed in their manufacturing capacity to meet expected demands4 7#d7 ,in order to foster a domestic ,,ppe supply chain1 ,united ,states industry needs a strong and consistent demand signal from the ,federal ,government providing the necessary certainty to expand production capacity investment in the ,united ,states4 7#e7 ,in order to effectively incentivize investment in the ,united ,states and the re-shoring of manufacturing1 long-term contracts must be no shorter than three years in duration4 7#f7 ,the ,united ,states needs a long-term investment strategy for the domestic production of ,,ppe items critical to the ,united ,states national response to a public health crisis1 including the ,,covid-#ai pandemic4 #c4 ,requirement of long-term contracts for domestically manufactured personal protective equipment 7a7 ,definitions ,in this section3 7#a7 ,appropriate congressional committees ,the term appropriate congressional committees means-- 7,a7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions1 the ,committee on ,finance1 the ,committee on ,homeland ,security and ,governmental ,affairs1 the ,committee on ,veterans' ,affairs1 and the ,committee on ,armed ,services of the ,senate2 and 7,b7 the ,committee on ,energy and ,commerce1 the ,committee on ,ways and ,means1 the ,committee on ,homeland ,security1 the ,committee on ,veterans' ,affairs1 and the ,committee on ,armed ,services of the ,house of ,representatives4 7#b7 ,covered ,secretary ,the term covered ,secretary means the ,secretary of ,homeland ,security1 the ,secretary of ,health and ,human ,services1 the ,secretary of ,defense1 the ,secretary of ,education1 and the ,secretary of ,veterans ,affairs4 7#c7 ,personal protective equipment ,the term personal protective equipment means surgical masks1 respirator masks and powered air purifying respirators and required filters1 face shields and protective eyewear1 gloves1 disposable and reusable surgical and isolation gowns1 and head and foot coverings1 or other gear or clothing used to protect an individual from the transmission of disease4 7#d7 ,united ,states ,the term ,united ,states means the #ej ,states1 the ,district of ,columbia1 and the possessions of the ,united ,states4 7b7 ,contract requirements ,beginning #ij days after the date of the enactment of this ,act1 in order to ensure the sustainment and expansion of personal protective equipment manufacturing in the ,united ,states and meet the needs of the current pandemic response1 any contract for the procurement of personal protective equipment entered into by a covered ,secretary1 or a covered ,secretary's designee1 shall-- 7#a7 be issued for a duration of at least #c years1 including a base period and all option periods1 to incentivize investment in the production of personal protective equipment and the materials and components thereof in the ,united ,states2 and 7#b7 be for personal protective equipment that-- 7,a7 is grown1 reprocessed1 reused1 or produced in the ,united ,states2 and 7,b7 when assembled outside the ,united ,states1 contains only materials and components that are grown1 reprocessed1 reused1 or produced in the ,united ,states4 7c7 ,availability exception ,paragraph 7#b7 of subsection 7b7 shall not apply to an item of personal protective equipment1 or component or material thereof-- 7#a7 that is1 or that includes1 a material listed in section #be4ajd of the ,federal ,acquisition ,regulation as one for which a non-availability determination has been made2 7#b7 as to which the covered ,secretary determines that a sufficient quantity of a satisfactory quality that is grown1 reprocessed1 reused1 or produced in the ,united ,states cannot be procured as1 and when1 needed at ,united ,states market prices2 or 7#c7 if1 after maximizing to the extent feasible sources consistent with subsection 7b71 the covered ,secretary certifies every #abj days that it is necessary to procure personal protective equipment under alternate procedures to respond to the immediate needs of a public health emergency4 7d7 ,report 7#a7 ,in general ,not later than #ij days after the date of the enactment of this ,act1 the ,director of the ,office of ,management and ,budget1 in consultation with the covered ,secretaries1 shall submit to the chairs and ranking members of the appropriate congressional committees a report on the procurement of personal protective equipment4 7#b7 ,elements ,the report required under paragraph 7#a7 shall include the following elements3 7,a7 ,the ,united ,states long-term domestic procurement strategy for ,,ppe produced in the ,united ,states1 including strategies to incentivize investment in and maintain ,united ,states supply chains for all ,,ppe sufficient to meet the needs of the ,united ,states during a public health emergency4 7,b7 ,an estimate of long-term demand quantities for all ,,ppe items procured by the ,united ,states4 7,c7 ,recommendations for congressional action required to implement the ,united ,states ,government's procurement strategy4 7,d7 ,a determination whether all notifications1 amendments1 and other necessary actions have been completed to bring the ,united ,states existing international obligations into conformity with the statutory requirements of this ,act4 7e7 ,authorization of transfer of equipment ,a covered ,secretary may transfer to the ,strategic ,national ,stockpile established under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 any excess personal protective equipment acquired under a contract executed pursuant to subsection 7b74 7f7 ,compliance with international agreements ,this ,act shall be applied in a manner consistent with ,united ,states obligations under international agreements4 #a4 ,short title ,this ,act may be cited as the ,make ,,ppe in ,america ,act4 #b4 ,findings ,congress makes the following findings3 7#a7 ,the ,,covid-#ai pandemic has exposed the vulnerability of the ,united ,states supply chains for1 and lack of domestic production of1 personal protective equipment 7,,ppe74 7#b7 ,the ,united ,states requires a robust1 secure1 and wholly domestic ,,ppe supply chain to safeguard public health and national security4 7#c7 ,issuing a strategy that provides the government's anticipated needs over the next three years will enable suppliers to assess what changes1 if any1 are needed in their manufacturing capacity to meet expected demands4 7#d7 ,in order to foster a domestic ,,ppe supply chain1 ,united ,states industry needs a strong and consistent demand signal from the ,federal ,government providing the necessary certainty to expand production capacity investment in the ,united ,states4 7#e7 ,in order to effectively incentivize investment in the ,united ,states and the re-shoring of manufacturing1 long-term contracts must be no shorter than three years in duration4 7#f7 ,to accomplish this aim1 the ,united ,states should seek to ensure compliance with its international obligations1 such as its commitments under the ,world ,trade ,organization's ,agreement on ,government ,procurement and its free trade agreements1 including by invoking any relevant exceptions to those agreements1 especially those related to national security and public health4 7#g7 ,the ,united ,states needs a long-term investment strategy for the domestic production of ,,ppe items critical to the ,united ,states national response to a public health crisis1 including the ,,covid-#ai pandemic4 #c4 ,requirement of long-term contracts for domestically manufactured personal protective equipment 7a7 ,definitions ,in this section3 7#a7 ,appropriate congressional committees ,the term appropriate congressional committees means-- 7,a7 the ,committee on ,homeland ,security and ,governmental ,affairs1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions1 the ,committee on ,finance1 the ,committee on ,veterans' ,affairs1 and the ,committee on ,armed ,services of the ,senate2 and 7,b7 the ,committee on ,homeland ,security1 the ,committee on ,oversight1 the ,committee on ,energy and ,commerce1 the ,committee on ,ways and ,means1 the ,committee on ,veterans' ,affairs1 and the ,committee on ,armed ,services of the ,house of ,representatives4 7#b7 ,covered ,secretary ,the term covered ,secretary means the ,secretary of ,homeland ,security1 the ,secretary of ,health and ,human ,services1 the ,secretary of ,defense1 and the ,secretary of ,veterans ,affairs4 7#c7 ,personal protective equipment ,the term personal protective equipment means surgical masks1 respirator masks and powered air purifying respirators and required filters1 face shields and protective eyewear1 gloves1 disposable and reusable surgical and isolation gowns1 head and foot coverings1 and other gear or clothing used to protect an individual from the transmission of disease4 7#d7 ,united ,states ,the term ,united ,states means the #ej ,states1 the ,district of ,columbia1 and the possessions of the ,united ,states4 7b7 ,contract requirements for domestic production ,beginning #ij days after the date of the enactment of this ,act1 in order to ensure the sustainment and expansion of personal protective equipment manufacturing in the ,united ,states and meet the needs of the current pandemic response1 any contract for the procurement of personal protective equipment entered into by a covered ,secretary1 or a covered ,secretary's designee1 shall-- 7#a7 be issued for a duration of at least #b years1 plus all option periods necessary1 to incentivize investment in the production of personal protective equipment and the materials and components thereof in the ,united ,states2 and 7#b7 be for personal protective equipment1 including the materials and components thereof1 that is grown1 reprocessed1 reused1 or produced in the ,united ,states4 7c7 ,alternatives to domestic production ,the requirement under subsection 7b7 shall not apply to an item of personal protective equipment1 or component or material thereof if1 after maximizing to the extent feasible sources consistent with subsection 7b71 the covered ,secretary-- 7#a7 maximizes sources for personal protective equipment that is assembled outside the ,united ,states containing only materials and components that are grown1 reprocessed1 reused1 or produced in the ,united ,states2 and 7#b7 certifies every #abj days that it is necessary to procure personal protective equipment under alternative procedures to respond to the immediate needs of a public health emergency4 7d7 ,availability exception 7#a7 ,in general ,subsections 7b7 and 7c7 shall not apply to an item of personal protective equipment1 or component or material thereof-- 7,a7 that is1 or that includes1 a material listed in section #be4ajd of the ,federal ,acquisition ,regulation as one for which a non-availability determination has been made2 or 7,b7 as to which the covered ,secretary determines that a sufficient quantity of a satisfactory quality that is grown1 reprocessed1 reused1 or produced in the ,united ,states cannot be procured as1 and when1 needed at ,united ,states market prices4 7#b7 ,certification requirement ,the covered ,secretary shall certify every #abj days that the exception under paragraph 7#a7 is necessary to meet the immediate needs of a public health emergency4 7e7 ,report 7#a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,director of the ,office of ,management and ,budget1 in consultation with the covered ,secretaries1 shall submit to the chairs and ranking members of the appropriate congressional committees a report on the procurement of personal protective equipment4 7#b7 ,elements ,the report required under paragraph 7#a7 shall include the following elements3 7,a7 ,the ,united ,states long-term domestic procurement strategy for ,,ppe produced in the ,united ,states1 including strategies to incentivize investment in and maintain ,united ,states supply chains for all ,,ppe sufficient to meet the needs of the ,united ,states during a public health emergency4 7,b7 ,an estimate of long-term demand quantities for all ,,ppe items procured by the ,united ,states4 7,c7 ,recommendations for congressional action required to implement the ,united ,states ,government's procurement strategy4 7,d7 ,a determination whether all notifications1 amendments1 and other necessary actions have been completed to bring the ,united ,states existing international obligations into conformity with the statutory requirements of this ,act4 7f7 ,authorization of transfer of equipment 7#a7 ,in general ,a covered ,secretary may transfer to the ,strategic ,national ,stockpile established under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 any excess personal protective equipment acquired under a contract executed pursuant to subsection 7b74 7#b7 ,transfer of equipment during a public health emergency 7,a7 ,amendment ,title ,v of the ,homeland ,security ,act of #bjjb 7#f ,u4,s4,c4 #caa et seq47 is amended by adding at the end the following3 #ebi4 ,transfer of equipment during a public health emergency 7a7 ,authorization of transfer of equipment ,during a public health emergency declared by the ,secretary of ,health and ,human ,services under section #cai7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7a771 the ,secretary1 at the request of the ,secretary of ,health and ,human ,services1 may transfer to the ,department of ,health and ,human ,services1 on a reimbursable basis1 excess personal protective equipment or medically necessary equipment in the possession of the ,department4 7b7 ,determination by ,secretaries 7#a7 ,in general ,in carrying out this section-- 7,a7 before requesting a transfer under subsection 7a71 the ,secretary of ,health and ,human ,services shall determine whether the personal protective equipment or medically necessary equipment is otherwise available2 and 7,b7 before initiating a transfer under subsection 7a71 the ,secretary1 in consultation with the heads of each component within the ,department1 shall-- 7i7 determine whether the personal protective equipment or medically necessary equipment requested to be transferred under subsection 7a7 is excess equipment2 and 7ii7 certify that the transfer of the personal protective equipment or medically necessary equipment will not adversely impact the health or safety of officers1 employees1 or contractors of the ,department4 7#b7 ,notification ,the ,secretary of ,health and ,human ,services and the ,secretary shall each submit to ,congress a notification explaining the determination made under subparagraphs 7,a7 and 7,b71 respectively1 of paragraph 7#a74 7#c7 ,required inventory 7,a7 ,in general ,the ,secretary shall-- 7i7 acting through the ,chief ,medical ,officer of the ,department1 maintain an inventory of all personal protective equipment and medically necessary equipment in the possession of the ,department2 and 7ii7 make the inventory required under clause 7i7 available1 on a continual basis1 to-- 7,i7 the ,secretary of ,health and ,human ,services2 and 7,,ii7 the ,committee on ,appropriations and the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate and the ,committee on ,appropriations and the ,committee on ,homeland ,security of the ,house of ,representatives4 7,b7 ,form ,each inventory required to be made available under subparagraph 7,a7 shall be submitted in unclassified form1 but may include a classified annex4 4 7,b7 ,table of contents amendment ,the table of contents in section #a7;b7 of the ,homeland ,security ,act of #bjjb 7,public ,law #ajg-bif2 #aaf ,stat4 #bace7 is amended by inserting after the item relating to section #ebh the following3 ,sec4 #ebi4 ,transfer of equipment during a public health emergency4 4 7#c7 ,strategic national stockpile ,section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is amended by adding at the end the following3 7#f7 ,transfers of items ,the ,secretary1 in coordination with the ,secretary of ,homeland ,security1 may sell drugs1 vaccines and other biological products1 medical devices1 or other supplies maintained in the stockpile under paragraph 7#a7 to a ,federal agency or private1 nonprofit1 ,state1 local1 tribal1 or territorial entity for immediate use and distribution1 provided that any such items being sold are-- 7,a7 within #a year of their expiration date2 or 7,b7 determined by the ,secretary to no longer be needed in the stockpile due to advances in medical or technical capabilities4 4 7g7 ,compliance with international agreements ,the ,president or the ,president's designee shall take all necessary steps1 including invoking the rights of the ,united ,states under ,article ,,iii of the ,world ,trade ,organization's ,agreement on ,government ,procurement and the relevant exceptions of other relevant agreements to which the ,united ,states is a party1 to ensure that the international obligations of the ,united ,states are consistent with the provisions of this ,act4 ,december #ai1 #bjbb,reported with an amendment